PROXIMAL HUMERUS, RIGHT, 9X160MM
Report
- Report Number
- 0009613350-2022-00006
- Event Type
- Malfunction
- Date Received
- January 4, 2022
- Date of Event
- November 19, 2021
- Report Date
- March 23, 2022
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- HSB
- UDI-DI
- 00889024505780
- PMA / PMN Number
- K181827
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDICAL PRODUCT: ANN BLUNT TIP SCREW 4X58MM; CATALOG#: 47-2486-058-40; LOT#: 3010686. ANN CORT BONE SCREW 4 X 26MM; CATALOG#: 47-2486-126-40; LOT#: 3048178. ANN CORT BONE SCREW 4 X 28MM; CATALOG#: 47-2486-128-40; LOT#: 3054458. ANN WASHER SMALL; CATALOG#: 47-2488-000-04; LOT#: 3025212. AFFIXUS PH NL CAP 0MM; CATALOG#: 47-2488-010-00; LOT#: 3073674. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT#: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00007, 0009613350-2022-00008, 0009613350-2022-00009.
CONCOMITANT MEDICAL PRODUCT: ANN BLUNT TIP SCREW 4X58MM; CATALOG#: 47-2486-058-40; LOT#: 3010686. ANN CORT BONE SCREW 4 X 26MM; CATALOG#: 47-2486-126-40; LOT#: 3048178. ANN CORT BONE SCREW 4 X 28MM; CATALOG#: 47-2486-128-40; LOT#: 3054458. ANN WASHER SMALL; CATALOG#: 47-2488-000-04; LOT#: 3025212. AFFIXUS PH NL CAP 0MM; CATALOG#: 47-2488-010-00; LOT#: 3073674. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT#: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00007, 0009613350-2022-00008, 0009613350-2022-00009.
EVENT DESCRIPTION: IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL ON (B)(6) 2021. AFTER 3 WEEKS FROM THE INITIAL, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. NO FURTHER OUTCOME. REVIEW OF RECEIVED DATA: NO MEDICAL DATA (LIKE X-RAYS OR MEDICAL RECORDS) RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET, SEE SURGICAL TECHNIQUE. SURGICAL TECHNIQUE SAP: THE SURGICAL TECHNIQUE 197-GLBL-EN EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. TURN SLOWLY CLOCKWISE TO TIGHTEN AND ENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION RELATED TO THE EVENT. CONCLUSION: IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL ON (B)(6) 2021. AFTER 3 WEEKS FROM THE INITIAL, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. NO FURTHER OUTCOME. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE INVESTIGATION IT CAN BE ASSUMED THAT THE FACTORS THAT LED AND/OR CONTRIBUTED TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOUR, IMPLANTATION PROCEDURE OR DESIGN FEATURES. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE BACKING OUT OF THE SCREW REMAINS UNKNOWN. CAPA CA-06074 IS ONGOING FOR THIS ISSUE OF SCREW BACKING OUT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00007-1, 0009613350-2022-00008-1, 0009613350-2022-00009-1.
IT WAS REPORTED THAT AFTER INITIAL SURGERY OF THE ANN NAIL SYSTEM ONE OF THE ANN BLUNT SCREWS BACKED OUT.
IT WAS REPORTED THAT AFTER INITIAL SURGERY OF THE ANN NAIL SYSTEM ONE OF THE ANN BLUNT SCREWS BACKED OUT.
INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478995 | PROXIMAL HUMERUS, RIGHT, 9X160MM | AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL | HSB | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3049698 | 00889024505780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | SEE H10 NARRATIVE |