FDA Adverse Event
Malfunction
Summary report: N
TURON SHOULDER
MDR report key: 2053451
·
Received March 1, 2011
Report
- Report Number
- 1644408-2011-00107
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- January 31, 2011
- Report Date
- January 31, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K080402
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
INSTRUMENT FAILURE - THE TURON PEG DRILL TOP BROKE OFF IN THE PT'S GLENOID, BUT WAS RETRIEVED. THIS PART WAS USED WHEN THE DRILL TIP BROKE OFF. THE PART WAS RETURNED AS PART OF INVESTIGATION (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TURON SHOULDER | GLENOID PEGGED | KWS | ENCORE MEDICAL, L.P. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | 804-25-121, LOT 5165L01B |