Screwdriver, Surgical
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
14 adverse event reports on file
- ERISMA-LP MISSep 13, 2023MalfunctionClariance Sas3009962553-2023-00002
- MANUAL SCREWDRIVER (MEDIUM) STST 0.9Feb 16, 2023InjuryJjgc S.a.3008261720-2022-14828
- STRAIGHT SCREWDRIVERAug 28, 2020MalfunctionSmith & Nephew, Inc.1020279-2020-04286
- TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTORJan 9, 2019MalfunctionI.t.s. Gmbh3004369035-2016-00007
- SCRDRIVER ANGLOct 12, 2017InjurySynthes Hagendorf3003875359-2017-10501
- STRAIGHT SCREWDRIVERFeb 20, 2017InjurySmith & Nephew, Inc.1020279-2017-00110
- SKYLINE CAM LOCKINGOct 19, 2011MalfunctionDepuy Spine2303795
- SKYLINE CAM LOCKINGSep 28, 2011MalfunctionDepuy Spine2273111
- CAPTIVE HEX SCREWDRIVERSep 20, 2004MalfunctionEndius, Inc.1057469-2004-00005
- ZIMMERJul 16, 1993InjuryZimmer34545-1993-00002
Event type breakdown
Recalls
6 recall events for this product code
- Aesculap, Inc.TerminatedDec 16, 2015
Flexible Screw Driver SJ706R;
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Z-0422-2016 · View FDA record ↗ - Aesculap, Inc.TerminatedDec 16, 2015
Flexible Bone Awl;
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Z-0423-2016 · View FDA record ↗ - Aesculap, Inc.TerminatedDec 16, 2015
Flexible Drill;
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Z-0424-2016 · View FDA record ↗ - Aesculap, Inc.TerminatedDec 16, 2015
Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on orde
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Z-0448-2016 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedJul 11, 2013
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND).
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Z-1685-2013 · View FDA record ↗ - Genesys Orthopedics Systems, LLCTerminatedUnknown
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Z-0040-2018 · View FDA record ↗
Registered firms
29 firms currently registered for this product code
Clearpoint Neuro Inc.
Carlsbad, CA, US
Bioplate, Inc.
Placentia, CA, US
Solco Biomedical Corp.
Carrollton, TX, US
Tyber Medical
Bethlehem, PA, US
Hive International Pvt Ltd.
Sialkot Punjab, PK
Triangle Manufacturing Co., Inc.
UPPER SADDLE RIVER, NJ, US
Tyber Medical
Bethlehem, PA, US
Askorn Medical
Cesson Sevigne Bretagne, FR
Medikan Co., Ltd.
Gangseo-gu Seoul, KR
Ortho Solutions Sdn Bhd
Prai, Penang Pulau Pinang, MY
Berger Surgical Medical Products Gmbh
Neuhausen ob Eck Baden-Wurttemberg, DE
Comfort Surgical Instruments
Sialkot Punjab, PK
Blache Medical Gmbh & Co. Kg
Wellendingen Baden-Wurttemberg, DE
Nextcon International
Sialkot Punjab, PK
Ustomed Instrumente Gmbh & Co. Kg
Tuttlingen Baden-Wurttemberg, DE
Tdm Usa Inc.
Bayside, NY, US
Rsb Spine Llc.
Wooster, OH, US
High-tech Quality Mfg. Inc.
Salt Lake City, UT, US
Elcon Medical Instruments Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Biedermann Motech Gmbh & Co. Kg
VS-SCHWENNINGEN Baden-Wurttemberg, DE
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Apex (guangzhou) Tools & Orthopedics Company
Guangzhou Guangdong, CN
Ortho-med, Inc.
Tigard, OR, US
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Tdm Co.,ltd
Gwangju, KR