MalfunctionKGS
ORTHOPAEDIC BIOSYSTEM LID
Received Oct 7, 2002 · Event occurred Sep 13, 2002
Report 420745 · MDR key 420745
Device
Generic name
Polymer Anchor
Manufacturer
Orthopaedic BiosystemsModel number
PRC5Catalog number
23-1588-01
Lot number
Q2004D1
Product problems
- Break
- Tip breakage
Patient
79 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DURING ROTATOR CUFF REPAIR USING 5.0MM OBC POLYMER SUTURE ANCHOR; ANCHOR TIP BROKE OFF IN SHAFT OF DRIVER. NO REMNANT OF SUTURE ANCHOR LEFT IN PT.