MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X48MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	47-2486-048-40
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery two months post initial implantation due to a backed out screw.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 - medical devices: the following nail and screws were implanted during the initial procedure, and it is unknown which screw exactly had backed out :- proximal humerus, left, long, 10x 240mm; item# 47-2496-241-09; lot# 3010780.Blunt tip screw, 4x48mm; item# 47-2486-048-40; lot# 2989723.Blunt tip screw, 4x50mm; item# 47-2486-050-40; lot# 3024737.Blunt tip screw, 4x44mm; item# 47-2486-044-40; lot# 3054383.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00415.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.
Event or Problem Description
No additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.Complaints are monitored per wt-wi 423801 complaint trending process in order to identify potential adverse trends.A single ap overview of the left shoulder taken before revision surgery was provided and reviewed by a radiologist.The x-ray shows an intramedullary nail and a proximal fixation with 3 screws.A radiolucent lesion of the proximal humeral diaphysis can be seen and bone quality is osteopenic.There is no implant fracture and implant alignment is maintained; however, one of the three proximal screws has retracted.As no other previous postoperative images are available for comparison, no assessment can be made on the initial position of the screw straight after implantation.Based on the analysis of the received x-ray, the reported event can be confirmed.As the devices involved in the reported event were not returned for investigation, a further product evaluation could not be performed and it is not possible to test the assembly of the involved parts.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.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.Multiple follow up mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00415-1.

• Brand Name: BLUNT TIP SCREW, 4X48MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17388147
• Report Number: 0009613350-2023-00416
• Device Sequence Number: 6302383
• Product Code: HSB
• UDI-Device Identifier: 00889024505483
• UDI-Public: (01)00889024505483(17)240229(10)2989723
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 47-2486-048-40
• Device Lot Number: 2989723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male