FDA Adverse Event
Malfunction
Summary report: N
1/8" HEX DRIVE
MDR report key: 2844963
·
Received October 24, 2012
Report
- Report Number
- 2249697-2012-02010
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 2, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HWC
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LOCKING SCREW OF THE TIBIAL BLOCK DID NOT LOCK WITH THE FLANGE OF THE TIBIAL BASE PLATE PROPERLY. THE FLANGE OF THE LOCKING SCREW LOCKED WITH THE NON-THREADED AREA OF THE FLANGE OF THE TIBIAL BASEPLATE. THE SURGEON TRIED TO UNLOCK THE LOCKING SCREW FROM THE BASEPLATE WITH THE 1/8" HEX DRIVE. THE TIP OF THE HEX DRIVER WAS BROKEN DURING UNLOCKING. THE TIP OF THE DRIVER WAS NOT REMAINED IN THE PT AND HAD ALREADY DISCARDED. THE SURGEON DECIDED TO IMPLANT THE BLOCK AND THE BASEPLATE BECAUSE THEIR LOCKING IS TIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1/8" HEX DRIVE | INSTRUMENT | HWC | STRYKER ORTHOPAEDICS MAHWAH | NA | SC6CO7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |