FDA Adverse Event
Malfunction
Summary report: N
TIBIAL ANKLE CLAMP ASSEMBLY
MDR report key: 2112237
·
Received April 29, 2011
Report
- Report Number
- 2249697-2011-00601
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 6, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER (B)(6), REPORTED VIA SALES REP (B)(6) THAT THE LOCKING WHEEL IS SPINNING FREELY AND NOT TIGHTENING AGAINST THE SPIKED PROXIMAL ROD AS IT SHOULD. THE CUSTOMER ADDED THAT THIS OCCURRED DURING SURGERY, AND THE SECOND ONE THAT WAS OPENED ALSO HAD THE SAME ISSUE BUT ANOTHER SET WAS AVAILABLE AS REPLACEMENT TO COMPLETE THE SURGERY, HENCE NO ADVERSE CONSEQUENCES OR DELAYS TO SURGERY WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIBIAL ANKLE CLAMP ASSEMBLY | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | CXN18 & L04K76 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |