FDA Adverse Event
Malfunction
Summary report: N
HIP DRILLS & GUIDES
MDR report key: 2193259
·
Received August 5, 2011
Report
- Report Number
- 1219602-2011-00126
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 12, 2011
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY
- Product Code
- NBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE ENTIRE TIP BROKE OFF AT THE POINT WHERE DRILL BIT MEETS SHOULDER INTO ASETABULUM. DRILL BIT STAYED IN BONE AND UNABLE TO RETRIEVE; NOT IMPINGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIP DRILLS & GUIDES | DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC | NBH | SMITH & NEPHEW ENDOSCOPY | 72201108 | 50227297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |