BLUNT TIP SCREW, 4X38MM
Report
- Report Number
- 0009613350-2022-00637
- Event Type
- Injury
- Date Received
- December 19, 2022
- Date of Event
- November 22, 2022
- Report Date
- January 23, 2023
- Manufacturer
- ZIMMERSWITZERLAND MANUFACTURING GMBH
- Product Code
- HSB
- UDI-DI
- 00889024505438
- PMA / PMN Number
- K200814
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). PROXIMAL HUMERUS, RIGHT, 7X160MM; ITEM# 47249616007, LOT# 3091684; BLUNT TIP SCREW, 4X34MM; ITEM# 47248603440, LOT# 3077767; BLUNT TIP SCREW, 4X42MM; ITEM# 47248604240, LOT# 3081945; BLUNT TIP SCREW, 4X50MM; ITEM# 47248605040, LOT# 3078232; CORTICAL BONE SCREW, 4X24MM; ITEM# 47248612440, LOT# 3091458; CORTICAL BONE SCREW, 4X24MM; ITEM# 47248612440, LOT# 3091460; PROXIMAL HUMERUS NAIL CAP, 0MM; ITEM# 47248801000, LOT# 3091386. REPORT SOURCE: FOREIGN: JAPAN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00635; 0009613350 - 2022 - 00636; 0009613350 - 2022 - 00638.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H6, H10. AS NO PRODUCTS WERE RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. NO MEDICAL REPORTS WERE PROVIDED. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT 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 LOCKING MECHANISM OF THE 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 NAIL PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. THEREFORE, NO DESIGN CHANGES WERE CONDUCTED. 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 INITIAL RIGHT SHOULDER SURGERY. APPROXIMATELY 2 MONTHS LATER, REVISION SURGERY WAS PERFORMED DUE TO SCREW MIGRATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2700244 | BLUNT TIP SCREW, 4X38MM | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ZIMMERSWITZERLAND MANUFACTURING GMBH | N/A | 3082107 | 00889024505438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Required Intervention| H | SEE H10 NARRATIVE |