BLUNT TIP SCREW, ÿ 4X46MM
Report
- Report Number
- 0009613350-2025-00091
- Event Type
- Injury
- Date Received
- March 7, 2025
- Date of Event
- January 8, 2025
- Report Date
- September 17, 2025
- Manufacturer
- ZIMMER GMBH
- Product Code
- HSB
- UDI-DI
- 00889024505476
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D10. PROXIMAL HUMERUS, RIGHT, LONG, ÿ 7X260MM ITEM# 47249626007 LOT# 3054420. BLUNT TIP SCREW, ÿ 4X46MM ITEM# 47248604640 LOT# 3201659. BLUNT TIP SCREW, ÿ 4X50MM ITEM# 47248605040 LOT# 3207861. CORTICAL BONE SCREW, ÿ 4X28MM ITEM# 47248612840 LOT# 3196589. CORTICAL BONE SCREW, ÿ 4X26MM ITEM# 47248612640 LOT# 3207882. CORTICAL BONE SCREW, ÿ 4X28MM ITEM# 47248612840 LOT# 3207888.
(B)(4). G2. REPORT SOURCE: SPAIN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM. HOWEVER, DUE TO THE LACK OF THE LOT NUMBER, AN ADDITIONAL LOT SEARCH COULD NOT BE PERFORMED. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. RADIOGRAPHIC IMAGES OF THE PROXIMAL RIGHT HUMERUS WERE RECEIVED AND ASSESSED BY A RADIOLOGIST (HCP) WITH THE FOLLOWING ASSESSMENT: "OBLIQUE FRACTURE OF THE PROXIMAL TO MID RIGHT HUMERAL DIAPHYSIS WITH PLACEMENT OF AN INTRAMEDULLARY ROD AND EVENTUAL LOOSENING OF THE DISTAL MOST SCREW WITHIN THE PROXIMAL HARDWARE." THE SURGICAL TECHNIQUE 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." IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPHIC IMAGES OF THE PROXIMAL RIGHT HUMERUS WERE RECEIVED AND ASSESSED BY A RADIOLOGIST (HCP) WITH THE FOLLOWING ASSESSMENT: "OBLIQUE FRACTURE OF THE PROXIMAL TO MID RIGHT HUMERAL DIAPHYSIS WITH PLACEMENT OF AN INTRAMEDULLARY ROD AND EVENTUAL LOOSENING OF THE DISTAL MOST SCREW WITHIN THE PROXIMAL HARDWARE." DISCHARGE NOTES PERTAINING TO THE INITIAL SURGERY WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL WITH THE FOLLOWING FINDINGS: THE PATIENT HAD SURGERY ON THE RIGHT UPPER ARM WITH A METAL ROD AND SCREWS TO FIX THE BONE. THE X-RAY SHOWS THE BONE IS IN A GOOD POSITION. THE ARM IS SUPPORTED IN A SLING BUT CAN BE REMOVED FOR GROOMING AND GENTLE PENDULUM EXERCISES. THE PATIENT WAS DISCHARGED ON THE FIRST DAY AFTER SURGERY. REVISION SURGERY NOTES WITH MINIMAL DICTATION WERE ALSO PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL, IDENTIFYING AN EXTRACTION OF THE AFFECTED SCREW. THE SURGICAL TECHNIQUE 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." IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT A PATIENT HAD A CLOSED REDUCTION AND OSTEOSYNTHESIS WITH AN ENDOMEDULLARY NAIL OF THE RIGHT HUMERUS. SUBSEQUENTLY, 70 DAYS LATER, THE PATIENT PRESENTED WITH ANTEROEXTERNAL PAIN AND FIRST FINGER PARESTHESIA. IT WAS CONFIRMED RADIOGRAPHICALLY THAT ONE OF THE PROXIMAL SCREWS HAD MIGRATED. AND UNDERWENT A REVISION, THE MIGRATED SCREW WAS EXPLANTED WITHOUT COMPLICATIONS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL PROCEDURE AND SUBSEQUENTLY, APPROXIMATELY 3 MONTHS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO SCREW MIGRATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 905926 | BLUNT TIP SCREW, ÿ 4X46MM | IMPLANT, TRAUMA | HSB | ZIMMER GMBH | 3204742 | 00889024505476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Hospitalization| R | SEE H11 NARRATIVE. |