FDA Adverse Event
Malfunction
Summary report: N
2.5MM SMALL-JOINT AGGRESSIVE CUTTER (5BX)
MDR report key: 4600850
·
Received March 13, 2015
Report
- Report Number
- 0002936485-2015-00160
- Event Type
- Malfunction
- Date Received
- March 13, 2015
- Date of Event
- January 27, 2015
- Report Date
- February 18, 2015
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GFF
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THIS RECORD WITH MANUFACTURER REPORT 0002936485-2015-00160 WAS FOUND TO BE A DUPLICATE OF MANUFACTURER REPORT 0002936485-2015-00112. THE DEVICE EVALUATION AND INVESTIGATION CONCLUSION CAN BE FOUND UNDER THE ORIGINAL RECORD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF THE ANKLE, THE TIP OF THE SHAVER SEPARATED FROM THE SHAFT. ALL PARTS WERE RECOVERED VERIFIED BY X- RAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF THE ANKLE, THE TIP OF THE SHAVER SEPARATED FROM THE SHAFT. ALL PARTS WERE RECOVERED VERIFIED BY X- RAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173287 | 2.5MM SMALL-JOINT AGGRESSIVE CUTTER (5BX) | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | GFF | STRYKER ENDOSCOPY-SAN JOSE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |