FDA Adverse Event
Malfunction
Summary report: N
IM REAMER SHAFT, AO FITTING, DOVETAIL 8X885MM
MDR report key: 2134099
·
Received May 13, 2011
Report
- Report Number
- 9610622-2011-00225
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 5, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THE ASSOCIATED DEVICE IS AS FOLLOWS: 1806-1250S LOT# K206795 GUIDE WIRE, BALL-TIPPED, STERILE 3X1250 MM.
Description of Event or Problem · 1
IMPLANT SURGEONS REPORTED TO THE SALES REP, THAT DURING A NAIL IMPLANTATION, THE GUIDE GOT STUCK IN THE REAMER SHAFT. THE SURGEONS USED ANOTHER DEVICE TO REAM THE SHINE BONE BUT THEY USED THE GUIDE (B)(4) TO IMPLANT THE NAIL. THERE WAS DELAY OF OVER 30 MINUTES TO FINISH THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IM REAMER SHAFT, AO FITTING, DOVETAIL 8X885MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |