Driver, Wire, And Bone Drill, Manual
Dental · 21 CFR 872.4120
Recent MDR events
3,399 adverse event reports on file
- GEAR COVER FOR SCREWDRIVER 90°Jul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07677
- GEAR FOR SCREWDRIVER 90°Jul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07678
- VSP SYSTEMJun 22, 2026Injury3d Systems Healthcare1724955-2026-00004
- ACCUPLANApr 16, 2026MalfunctionMedcad3009196021-2026-00008
- ACCUPLAN SYSTEMMar 19, 2026MalfunctionMedcad3009196021-2026-00007
- VSP SYSTEMMar 17, 2026Injury3d Systems Healthcare1724955-2026-00003
- GEAR FOR SCREWDRIVER 90°Mar 13, 2026MalfunctionSynthes Gmbh8030965-2026-02495
- ACCUPLAN, ACCUPLATE 3DTIMar 10, 2026MalfunctionMedcad3009196021-2026-00006
- ACCUPLANMar 5, 2026MalfunctionMedcad3009196021-2026-00004
- ACCUPLANFeb 25, 2026MalfunctionMedcad3009196021-2026-00003
Event type breakdown
Recalls
11 recall events for this product code
- Stryker Instruments Div. of Stryker CorporationTerminatedOct 28, 2013
REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System
It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma
Z-0092-2014 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedNov 16, 2011
IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker Instruments, Kalamazoo, MI.
There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli
Z-0195-2012 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedNov 16, 2011
IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI.
There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli
Z-0196-2012 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedNov 16, 2011
Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments, Kalamazoo, MI.
There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli
Z-0197-2012 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedNov 16, 2011
Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker Instruments, Kalamazoo, MI.
There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli
Z-0198-2012 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedNov 16, 2011
Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2, Stryker Instruments, Kalamazoo, MI.
There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli
Z-0199-2012 · View FDA record ↗ - Straumann Manufacturing Inc.TerminatedMar 9, 2006
Thermoplastic templates, single tooth
Pilot drills may not fully extend through drill guide in template products
Z-0602-06 · View FDA record ↗ - Straumann Manufacturing Inc.TerminatedMar 9, 2006
Thermoplastic templates, free-end situation
Pilot drills may not fully extend through drill guide in template products
Z-0603-06 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedAug 23, 2005
Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.
Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
Z-1389-05 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedAug 23, 2005
Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.
Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
Z-1390-05 · View FDA record ↗
Registered firms
76 firms currently registered for this product code
Materialise Usa, Llc.
Plymouth, MI, US
Kls-martin L.p.
Jacksonville, FL, US
Medcad
Plano, TX, US
Synthes Gmbh
Selzach Solothurn, CH
Precision Edge Surgical Products Company
Sault Sainte Marie, MI, US
Acumed Llc
Hillsboro, OR, US
Materialise N.v.
LEUVEN Vlaams Brabant, BE
Materialise Ukraine, Rep. Office
Kyiv Kyyiv, Misto, UA
Stryker Instruments
Portage, MI, US
Biomet Microfixation
Jacksonville, FL, US
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Jabil Inc. (brandywine)
W Chester, PA, US
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Avalign Instruments & Implants
FORT WAYNE, IN, US
Immersivetouch, Inc.
Chicago, IL, US
Medical Modeling - A 3d Systems Company
Littleton, CO, US
Orchid Unique
Bridgeport, MI, US
The Anspach Effort, Inc.
Palm Bch Gdns, FL, US
Straumann Manufacturing, Inc.
Mansfield, TX, US
Insight Surgery Houston
Houston, TX, US
Materialise Sdn Bhd
Petaling Jaya Selangor, MY
Depuy Synthes Sales
Bridgewater, MA, US
510(k) clearances
32 clearances for this product code
- 3D Systems, Inc.Jun 3, 2026
K261826 · VSP System (Titanium Palatal Splint)
- Materialise NVFeb 21, 2025
K243637 · Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
- Techfit Digital Surgery, Inc.Dec 11, 2024
K242263 · TECHFIT DISRP® System
- Techmah CmfOct 2, 2023
K231520 · tmCMF Solution
- Techfit Digital SurgeryJun 23, 2023
K230276 · TECHFIT DISRP® System
- MedcadMar 7, 2023
K223024 · MedCAD AccuPlan System
- 3D Lifeprints UK , Ltd.Sep 30, 2022
K220366 · EmbedMed
- Vha DeanAug 11, 2022
K220648 · OMF ASP System