FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL DRIVER SHAFT
MDR report key: 1112746
·
Received August 11, 2008
Report
- Report Number
- 2249697-2008-00229
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 16, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HXX
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED BY CUSTOMER VIA SALES REP. THAT "DURING THE SURGERY, WHEN HE IMPLANTED THE SECOND SCREW, (CANCELLOUS BONE SCREW) WITH THE (UNIVERSAL DRIVER SHAFT), THE TIP OF THE UNIVERSAL DRIVER STAFF WAS BROKEN. THE PART OF THE ITEM WAS RECOVERED, AND THE SCREW WAS RETRIEVED WITH THE (STRAIGHT DRIVER SHAFT) AVAILABLE. THE SURGEON ALLEGED THAT HE DECIDED NOT TO IMPLANT ANOTHER SCREW TO REPLACE THE REMOVED ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL DRIVER SHAFT | INSTRUMENT | HXX | STRYKER ORTHOPAEDICS MAHWAH | NA | F1V3379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |