BLUNT TIP SCREW,4X48MM
Report
- Report Number
- 0009613350-2022-00533
- Event Type
- Injury
- Date Received
- October 14, 2022
- Date of Event
- September 19, 2022
- Report Date
- February 9, 2023
- Manufacturer
- ZIMMER MANUFACTURING SWITZERLAND GMBH
- Product Code
- HSB
- UDI-DI
- 00889024505483
- PMA / PMN Number
- K181827
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MEDICAL DEVICES; PROXIMAL HUMERUS, LEFT, 9X160MM ITEM# 47-2496-161-09 LOT# 3078853, BLUNT TIP SCREW, 4X48MM ITEM# 47-2486-048-40 LOT# 3073797, BLUNT TIP SCREW, 4X50MM ITEM# 47-2486-050-40 LOT# 3010668, BLUNT TIP SCREW, 4X50MM ITEM# 47-2486-050-40 LOT# 3024741, TORQUE LIMITING HANDLE ITEM# 27923 LOT# N/A, ANN CORT BONE SCREW 4 X 30MM , ITEM# 47-2486-130-40 , LOT# 3024383, ANN CORT BONE SCREW 4 X 30MM , ITEM# 47-2486-130-40 , LOT# 3081983, ANN SPIDER WASHER , ITEM# 47-2488-000-05 , LOT# 3008333, AFFIXUS PH NL CAP 0MM , ITEM# 47-2488-010-00 LOT# 3076782. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 -2022 -00532, 0009613350 -2022 -00534, 0009613350 -2022 -00535, 0009613350 -2022 -00536. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. AS NEITHER PRODUCTS NOR PICTURES OF THE PRODUCTS WERE RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. BASED ON THE INVESTIGATION, IT CAN BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS CONTRIBUTING TO THE MIGRATION OF THE SCREW MIGHT COULD BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE AFFIXUS NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE AFFIXUS® NATURAL NAIL® PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO SCREW MIGRATION 3-MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2446101 | BLUNT TIP SCREW,4X48MM | TRAUMA PROSTHESIS | HSB | ZIMMER MANUFACTURING SWITZERLAND GMBH | N/A | 3048866 | 00889024505483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention| H |