FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE HIP STRAI
MDR report key: 2033546
·
Received March 30, 2011
Report
- Report Number
- 1219602-2011-00052
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- February 17, 2011
- Report Date
- March 1, 2011
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TWO USED BLADES WERE RETURNED FOR EVALUATION. EACH BLADE IS BENT. INNER BLADES ARE GALLED AT THE DISTAL ENDS AND PROXIMAL ENDS. THE BENDING OF THE BLADES CAUSED AN ABNORMAL METAL-TO-METAL CONDITION RESULTING IN THE SHEDDING. CONCLUSION: IMPROPER USE.(B)(4).
Description of Event or Problem · 1
BLADE SHEDD DURING USE; MOST OF THE DEBRIS COULD BE REMOVED BY FLUSHING THE JOINT. MINOR FRAGMENTS STILL REMAIN IN THE JOINT. DURING STANDARD SOFT TISSUE RESECTION IN THE HIP BOTH BLADES SHOWN METAL SHEDDING; NO SIDE LOAD WAS APPLIED TO THE BLADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE HIP STRAI | FULL RADIUS BLADE,EP-1 LONG, | HAB | SMITH & NEPHEW ENDOSCOPY | 7205341 | 50546381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |