FDA Adverse Event
Injury
Summary report: N
1.3 MM SQUARE SCREWDRIVER
MDR report key: 3102238
·
Received May 9, 2013
Report
- Report Number
- 0001825034-2013-01343
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 11, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- LXH
- PMA / PMN Number
- PEXEMPT
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE RETURNED DEVICE FOUND EVIDENCE TO SUGGEST DEFORMATION PRIOR TO OVERLOAD FRACTURE.
Additional Manufacturer Narrative · 1
EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT A TRAUMA FOOT PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE WHILE THE SURGEON WAS INSERTING THE SCREW WITH THE RATCHET SCREWDRIVER, THE HEAD OF THE SCREWDRIVER FRACTURED OFF INTO THE SCREW. THE SURGEON ATTEMPTED TO REMOVED THE FRACTURED PIECE FROM THE SCREW BUT WAS UNABLE TO. AS A RESULT, THE FRACTURED PIECE REMAINED IN THE SCREW AND WAS IMPLANTED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204496 | 1.3 MM SQUARE SCREWDRIVER | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | BIOMET ORTHOPEDICS | N/A | OV117425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| S |