FDA Adverse Event
Malfunction
Summary report: N
MANTIS CANNULATED MODULAR AWL
MDR report key: 1487047
·
Received August 6, 2009
Report
- Report Number
- 9617544-2009-00328
- Event Type
- Malfunction
- Date Received
- August 6, 2009
- Date of Event
- July 24, 2009
- Report Date
- July 28, 2009
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- HWJ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
TIP OF THE CANNULATED AWL (B) (4) BROKE WHEN SURGEON USED IT TO PUSH INTO THE PT'S VERTEBRAL WITH HAND. THE CANNULATED T-HANDLE RATCHET BROKE INTO PIECES WHEN SURGEON USED IT WITH THE CANNULATED TAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANTIS CANNULATED MODULAR AWL | INSTRUMENT | HWJ | STRYKER SPINE BORDEAUX | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |