FDA Adverse Event
Injury
Summary report: N
DEK 6" GAUGE STRAIGHT
MDR report key: 2028202
·
Received March 11, 2011
Report
- Report Number
- 2648666-2011-00068
- Event Type
- Injury
- Date Received
- March 11, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 14, 2011
- Manufacturer
- STRYKER INSTRUMENTS PUERTO RICO
- Product Code
- HRX
- PMA / PMN Number
- K032473
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WILL RETAIN THE PRODUCT FOR THEIR INTERNAL REVIEW. RISK MANAGEMENT HAS ADVISED THAT THE PRODUCT WILL BE RETURNED TO THE MFR ONCE THEIR EVAL IS COMPLETE. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
DURING A PERCUTANEOUS DECOMPRESSION CASE (L5/S1), THE AUGER SHAFT BROKE WHILE IN THE SURGICAL SITE. A SMALL INCISION WAS MADE TO REMOVE THE BROKEN PIECE. NO DEVICE FRAGMENTS WERE LEFT BEHIND, AS VERIFIED BY FLUOROSCOPY. THE PROCEDURE WAS COMPLETED AS PLANNED AND THE PT IS DOING WELL POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEK 6" GAUGE STRAIGHT | ARTHROSCOPE | HRX | STRYKER INSTRUMENTS PUERTO RICO | 10289012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |