LARGE AO COUPLING ASNIS III HALL FITTING
Report
- Report Number
- 0008031020-2013-00412
- Event Type
- Malfunction
- Date Received
- November 5, 2013
- Date of Event
- October 15, 2013
- Report Date
- October 15, 2013
- Manufacturer
- STRYKER GMBH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
INVESTIGATION SUMMARY: THE REPORTED EVENT THAT THE ASSEMBLY WOBBLED COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED. TESTS WERE PERFORMED TO TRY TO REPRODUCE THE FAILURE. USING THE DEVICE IN COMBINATION WITH A HUDSON COUPLING REF 4100-135, A GAP COULD BE SEEN WHEN INSERTING (ONLY IN ONE WAY), MAKING THE ASSEMBLY WOBBLING. THIS IS CAUSED BY THE DESIGN OF THE HUDSON COUPLING. R&D WAS ASKED TO PROVIDE SOME INFORMATION REGARDING THE REPORTED COMPLAINTS. THEY STATED: THE 4100-135-000 HUDSON / MODIFIED TRINKLE DRILL ATTACHMENT IS DESIGNED TO ACCEPT BOTH THE HUDSON STYLE AND MODIFIED TRINKLE STYLE BACK-END. IN ORDER FOR THE ATTACHMENT TO WORK WITH BOTH STYLES OF BACK-ENDS, THE TOLERANCES HAVE TO BE A LITTLE BIT LOOSER FOR THE MODIFIED TRINKLE STYLE AND SOME AMOUNT OF WOBBLE ENDED UP BEING A COMPROMISE TO ALLOW THE ATTACHMENT TO FIT BOTH BACK-ENDS. IN ADDITION, THERE ISN¿T A STANDARD FOR THE DESIGN OF THE BACK-ENDS, SO THE ATTACHMENT FIT CAN BE BETTER OR WORSE DEPENDING ON THE DESIGN OF THE BACK-END AND THE MANUFACTURER¿S TOLERANCES. THE GAP DESCRIBED BELOW IS NORMAL DUE TO THE DESIGN. THE ATTACHMENT WILL COMPLETELY CLOSE (NO GAP) WHEN USING A HUDSON STYLE BACK-END, BUT THERE WILL BE A GAP WHEN USING A MODIFIED TRINKLE BACK-END. ATTACHED A FILE WITH PICTURES OF 4100-135-000 AND A 4100-235-000 HUDSON / MODIFIED TRINKLE ATTACHMENTS WITH BOTH MODIFIED TRINKLE AND HUDSON BACK-ENDS INSTALLED. IT CAN BE SEEN IN THE FILE THAT THE GAP IS PRESENT WITH THE MODIFIED TRINKLE BACK-END BUT NON-EXISTENT WITH THE HUDSON BACK-END. [...] RECOMMENDATIONS WOULD BE TO USE AN AO ATTACHMENT DIRECTLY INTO THE HANDPIECE(4100-110 OR 4100-210). THIS SHOULD REDUCE THE OVERALL WEIGHT, LENGTH, AND WOBBLE. THE QUICK-CONNECTS MUST ALLOW FOR MANUFACTURING TOLERANCES AND DIFFERENT MANUFACTURERS DESIGNS SO THEY AREN¿T ALWAYS A PERFECT FIT, WHICH IS COMPOUNDED IN THIS INSTANCE SINCE THERE ARE TWO QUICK CONNECTS USED. REDUCING THE CONNECTION POINTS SHOULD REDUCE THE AMOUNT OF WOBBLE. REDUCING THE WEIGHT AND LENGTH SHOULD ALSO REDUCE THE AMOUNT OF VIBRATION TRANSMITTED TO THE USER¿S HAND AND IMPROVE CONTROL. ANOTHER OPTION COULD BE USING A KEYLESS CHUCK IN PLACE OF THE 4100-135 ATTACHMENT. THIS WOULDN¿T REDUCE THE WEIGHT OR LENGTH, BUT WOULD REDUCE THE NUMBER OF QUICK-CONNECTS. THE EVENT INDICATES A POTENTIAL NON CONFORMITY. THE DEVICE COULD BE IMPROVED; THEREFORE A POTENTIAL NC WAS RAISED IN THE SYSTEM. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT COMMUNICATED. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE COULD BE ATTRIBUTED TO THE DEVICE USED IN COMBINATION WITH THIS REPORTED COUPLING. DEVICE WAS NOT RETURNED.
AS THE SURGEON WAS DRILLING FOR THE LAG SCREW THE DRILL WAS WOBBLING. IT WAS DETERMINED THAT THE CHUCK WAS CAUSING THE ISSUE. THIS HOSPITAL/SURGEON DOES NOT ALLOW ACCESS TO PATIENT MEDICAL RECORDS OF ANY KIND.
AS THE SURGEON WAS DRILLING FOR THE LAG SCREW THE DRILL WAS WOBBLING. IT WAS DETERMINED THAT THE CHUCK WAS CAUSING THE ISSUE. THIS HOSPITAL/SURGEON DOES NOT ALLOW ACCESS TO PATIENT MEDICAL RECORDS OF ANY KIND. REP REPORTED THAT THE CHUCK WAS REMOVED FROM SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570302 | LARGE AO COUPLING ASNIS III HALL FITTING | INSTRUMENT | LXH | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |