TIP FOR DHS/DCS IMPACTOR (338.28)
Report
- Report Number
- 2530088-2013-10489
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- August 9, 2011
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- HWA
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(6) 2011. PLACEHOLDER.
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE VISUAL INSPECTION DURING MANUFACTURING REVIEW REVEALED THE PLASTIC PORTION OF THE DEVICE AT THE TOP NEAR THE ENGAGEMENT GROOVE WAS BROKEN. THE BROKEN PORTION APPEARS TO BE BROKEN OFF AT APPROX. 45 DEGREE SHEAR ANGLE. THE SHEAR STRENGTH WAS APPARENTLY EXCEEDED DURING NORMAL POST MANUFACTURING USE CAUSING BREAKS IN THE MATERIAL. THE THREADED STEM SHOWED SIGNS OF NORMAL POST MANUFACTURING WEAR. THE PRODUCT EVALUATION FURTHER DETERMINED THE DEVICE WAS DAMAGED. IT IS NOT POSSIBLE TO KNOW IF THE INSTRUMENT WAS USED CORRECTLY. THE DEVICE MEETS ALL THE MANUFACTURING SPECIFICATIONS THEREFORE; THE COMPLAINT IS INVALID.
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVALUATION REPORTED THE TIP OF THE HANDLE IS DAMAGED. THERE ARE MULTIPLE GOUGES IN ONE OF THE PRONGS AND THE OTHER PRONG IS FRACTURED COMPLETELY. THE FRACTURED PIECE WAS NOT RETURNED. THE TIP OF THE IMPACTOR IS MADE FROM RADEL. IT WAS CHANGED TO THIS MATERIAL IN THE 90'S DUE TO FREQUENT COMPLAINTS OF BREAKAGE USING THE PREVIOUS MATERIAL. THE DEVICE IS OBVIOUSLY DAMAGED. IT IS NOT POSSIBLE TO KNOW IF THE INSTRUMENT WAS USED CORRECTLY. ANOTHER PART WAS RETURNED WITH THE COMPLAINT WHICH APPEARS TO BE A REPAIR PART . THERE IS NO MENTION OF THIS IN THE COMPLAINT. IT MAY HAVE BEEN USED TO HELP SEAT THE PLATE SINCE THE WRENCH WAS BROKEN (THE WRENCH IS USED TO HELP GUIDE THE IMPACTOR). THE IMPACTOR IS ALSO SUBJECT TO REPETITIVE HAMMERING AND WILL WEAR OVER TIME. THE MANUFACTURING RECORD SHOWS THAT THE DEVICE WAS MANUFACTURED IN 1998, WHICH SUGGESTS THAT THIS PART HAS BEEN IN USE FOR A LONG PERIOD. FROM A PRODUCT DEVELOPMENT STANDPOINT, THIS COMPLAINT IS CONSIDERED INVALID.
CONSULTANT REPORTED: DURING OPEN REDUCTION INTERNAL FIXATION PROCEDURE OF THE RIGHT HIP, THE T PART OF THE HANDLE OF THE INSERTION HANDLE (338.302) FOR THE SCREWS BROKE AND WOULD NOT ENGAGE THE SCREW. THE HANDLE KEPT FREE-SPINNING ON THE SHAFT. THE SURGEON USED THE TIP FOR THE IMPACTOR (338.26) TO POSITION THE PLATE CORRECTLY. UPON HITTING THE IMPACTOR TIP AGAINST THE PLATE, THE TIP OF THE IMPACTOR BROKE OFF BUT NOT INTO THE WOUND. NO FRAGMENTS TO RETRIEVE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THIS IS 1 OF 2 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172747 | TIP FOR DHS/DCS IMPACTOR (338.28) | HWA | SYNTHES BRANDYWINE | A4HA152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |