NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
Report
- Report Number
- 0009610622-2014-00542
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- September 14, 2014
- Report Date
- September 14, 2014
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
EVALUATION REVEALED THE NAIL HANDLE AND THE NAIL HOLDING SCREW TO BE THE SUBJECT PRODUCTS. A REVIEW OF THE MANUFACTURING / INSPECTION RECORDS REVEALED NO DISCREPANCIES. THE DEVICES WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICES HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2002 AND 2011) WE PRE-SUPPOSE THAT THE DEVICES HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED WITHOUT ANY PROBLEMS. EVALUATION DID NOT REVEAL ANY DISCREPANCIES IN MATERIAL OR MANUFACTURING. SIGNIFICANT FRETTING MARKS RUNNING OVER THE WHOLE CIRCUMFERENCE WERE VISIBLE ON THE OUTER SURFACE OF THE SHAFT OF THE NAIL HOLDING SCREW (NHS) CLOSE TO THE BEGINNING OF THE THREAD. CORRESPONDING FRETTING MARKS WERE ALSO FOUND INSIDE THE TUBE OF THE NAIL HANDLE. FRETTING MARKS ARE A RARE BUT KNOWN REACTION IF THESE MATERIALS COME IN CONTACT WHICH EACH OTHER. DURING SCREWING INTO THE NAIL IT IS POSSIBLE THAT THE NHS GETS IN CONTACT WITH THE INNER SURFACE OF THE TUBE OF THE NAIL HANDLE AND FRICTION OCCURS DUE TO A SUBOPTIMAL (SLIGHT OBLIQUE) AXIAL INSERTION (USER RELATED). IN COMBINATION WITH SMALL TOLERANCES IT IS POSSIBLE THAT COLD WELDING OCCURS. THE FOUND FRETTING MARKS ON THE INSTRUMENTS RETURNED INDICATE THAT MOST LIKELY COLD WELDING HAD OCCURRED IN THIS ACTUAL CASE DUE TO REPEATED SUBOPTIMAL (SLIGHT OBLIQUE) AXIAL INSERTION. A PROCESS CHANGE WAS ALREADY PERFORMED IN 2004 TO PREVENT FRETTING REGARDING THE NAIL HOLDING SCREW (SURFACE COATING WAS REMOVED). NO FURTHER ACTIONS WERE INITIATED. THE RETURNED NHS WAS MANUFACTURED POST TO THE CHANGE. ANYWAY, THE CHANGE DOES NOT PREVENT A USER ERROR DUE TO OBLIQUE INSERTION. THE CASE IS ATTRIBUTED TO AN INADEQUATE HANDLING BY THE USER. NO NON-CONFORMITY WAS IDENTIFIED.
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
WHEN ATTACHING THE NAIL HOLDING BOLT TO THE NAIL THROUGH THE "U" SHAPED NAIL ATTACHMENT FOR THE TIBIAL NAIL THE NAIL HOLDING BOLT BECAME STUCK AND WOULDN'T ENGAGE THE NAIL END NOR MOVE FORWARD OR BACKWARD. THE BOLT BECAME LODGED IN THE ATTACHMENT AND WAS PRACTICALLY COLD WELDED TO THE ATTACHMENT. HAD TO USE MALLET AND BEAT THE BOLT OUT OF ATTACHMENT. ONCE NAIL HOLDING BOLT WAS OUT WE TRIED ANOTHER NAIL HOLDING BOLT AND THE BOLT WOULD NOT SEAT PROPERLY. THERE IS SOMETHING INSIDE THE SLOT FOR THE NAIL HOLDING BOLT PREVENTING THE BOLT TO SUCCESSFULLY ATTACH THE IMPLANT. HAD TO INSERT NAIL WITH STICK PLATE SCREWED INTO NAIL AND FREEHAND ALL LOCKING HOLES ADDING CONSIDERABLE AMOUNT OF TIME TO CASE AS WELL AS DIFFICULTY.
WHEN ATTACHING THE NAIL HOLDING BOLT TO THE NAIL THROUGH THE "U" SHAPED NAIL ATTACHMENT FOR THE TIBIAL NAIL THE NAIL HOLDING BOLT BECAME STUCK AND WOULDN'T ENGAGE THE NAIL END NOR MOVE FORWARD OR BACKWARD. THE BOLT BECAME LODGED IN THE ATTACHMENT AND WAS PRACTICALLY COLD WELDED TO THE ATTACHMENT. HAD TO USE MALLET AND BEAT THE BOLT OUT OF ATTACHMENT. ONCE NAIL HOLDING BOLT WAS OUT WE TRIED ANOTHER NAIL HOLDING BOLT AND THE BOLT WOULD NOT SEAT PROPERLY. THERE IS SOMETHING INSIDE THE SLOT FOR THE NAIL HOLDING BOLT PREVENTING THE BOLT TO SUCCESSFULLY ATTACH THE IMPLANT. HAD TO INSERT NAIL WITH STICK PLATE SCREWED INTO NAIL AND FREEHAND ALL LOCKING HOLES ADDING CONSIDERABLE AMOUNT OF TIME TO CASE AS WELL AS DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623664 | NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | STRYKER TRAUMA KIEL | K796541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |