CORAIL AMT NECK SEG 135D STD
Report
- Report Number
- 1818910-2024-20089
- Event Type
- Malfunction
- Date Received
- September 24, 2024
- Date of Event
- January 1, 2024
- Report Date
- September 24, 2024
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- LXH
- UDI-DI
- 10603295325161
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿STD 135 CORAIL NECK TRIAL LOCKING RING WAS NOT SITTING FLUSH AND HAS BEEN BENT OUT OF ITS NOTCH MEANING THE HEAD TRIALS CANNOT BE LOCKED ONTO THIS TRIAL. NOT USABLE IN CURRENT STATE¿. THE PRODUCT RETURNED TO MEDTECH ORTHOPAEDICS FOR EVALUATION. THE MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS REVEALED THAT THE CORAIL AMT NECK SEG 135D STD HAS THE CIRCLIPS RING DEFORMED. ADDITIONALLY, THE DEVICE EXHIBITS AN OVERALL WORN APPEARANCE CONSISTENT WITH NORMAL AND CONSTANT USAGE. A FUNCTIONAL TESTING WAS NOT PERFORMED AS THE MATING DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BASED ON THE OBSERVED CONDITION OF THE CIRCLIPS RING, IT IS REASONABLE THAT THE DEFORMATION CONTRIBUTES TO THE REPORTED ASSEMBLING ISSUES. THE OBSERVED CONDITION OF THE DEVICE APPEARS TO BE A RESULT FROM A COMBINATION OF HEAVY USE AND EXPOSURE TO UNINTENDED FORCES, SUCH AS PRYING MOTIONS APPLIED DURING REPEATED ASSEMBLY AND DISASSEMBLY CYCLES WITH THE MATING DEVICE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL AMT NECK SEG 135D STD WOULD HAVE CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "STD 135 CORAIL NECK TRIAL LOCKING RING WAS NOT SITTING FLUSH AND HAS BEEN BENT OUT OF ITS NOTCH MEANING THE HEAD TRIALS CANNOT BE LOCKED ONTO THIS TRIAL. NOT USABLE IN CURRENT STATE." THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT 'L94005, CORAIL AMT NECK SEG 135D STD' HAD BENT. POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR BY USE OF EXCESSIVE FORCE IN A PRYING MOTION AND OVERLOAD OF THE MATERIAL. THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF UNABLE TO ASSEMBLE. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL AMT NECK SEG 135D STD WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: B5 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
ADDITIONAL INFORMATION WAS RECEIVED: THE EXACT COMPLAINT WAS THAT THE HEAD TRIAL WAS NOT LOCKING ONTO THE NECK TRIAL DUE TO THE LOCKING RING BEING BENT OUT OF SHAPE.
STD 135 CORAIL NECK TRIAL LOCKING RING WAS NOT SITTING FLUSH AND HAS BEEN BENT OUT OF ITS NOTCH MEANING THE HEAD TRIALS CANNOT BE LOCKED ONTO THIS TRIAL. NOT USABLE IN CURRENT STATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1138348 | CORAIL AMT NECK SEG 135D STD | FEMORAL TRIALS | LXH | DEPUY IRELAND - 9616671 | NB104283 | 10603295325161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |