MAUDE Adverse Event Report: ZIMMER GMBH BLUNT TIP SCREW, ÿ 4X58MM; IMPLANT, TRAUMA

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Blunt tip screw, ã¿ 4x40mm item# 47248604040 lot# 3193667.Blunt tip screw, ã¿ 4x40mm item# 47248604040 lot# 3207884.Blunt tip screw, ã¿ 4x58mm item# 47248605840 lot# 3189215.Blunt tip screw, ã¿ 4x42mm item# 47248604240 lot# 3207863.Cortical bone screw, ã¿ 4x30mm item# 47248613040 lot# 3197007.Cortical bone screw, ã¿ 4x32mm item# 47248613240 lot# 3189217.Washer small item# 47248800004 lot# 3177551.Proximal humerus nail cap, 0mm item# 47248801000 lot# 3200542.G2 report source: japan.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.
Event or Problem Description
It was reported that an ann nail surgery was performed.Subsequently, after 1 month from the initial surgery, the surgeon found that all proximal screws had migrated out of the proper position.The patient complained of pain and revision surgery was performed and removed all implants.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11.The products involved in the reported event were not returned for investigation; however, pictures were provided and reviewed.All screws exhibit flattened and polished threads.The female threads on the nail where the screw are insert-ed, show signs deformation, most likely due to the engagement with the screws.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 complaint trending process in order to identify potential adverse trends.Six radiographs were received and assessed by a radiologist.On a pre-revision surgery image, a transverse displaced humeral neck fracture is visible.An image taken immediately after implantation, shows that intramedullary screw and nail fixation has been performed, and the alignment is improved.On subsequently follow-up images, progressive retraction of the screws without change in fracture alignment is noted.Bone quality is osteopenic on all images.Based on the provided radiographs, the reported of the screws migrated could be confirmed.Based on the provided radiographs, the reported event of the screws migration could be confirmed.The provided pictures show wear and deformation on the devices, which are consistent with the migration.How-ever, as the devices were not returned, further evaluation could not be performed.Based on the investigation, it can be assumed that the migration of the screws may have been influenced by multiple factors, potentially including patient¿s condition, behavior or implantation procedure.However, if and to what extent any of these aspects may have influenced the migration of the screws remains unknown, and the involvement of other factors cannot be ruled out.Based on similar events, an additional deeper investigation was performed which identified that the corelock mechanism of the affixus nail could be a potential contributing factor.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screws.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.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: BLUNT TIP SCREW, ÿ 4X58MM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER 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: 21021123
• Report Number: 0009613350-2024-00628
• Device Sequence Number: 9181264
• Product Code: HSB
• UDI-Device Identifier: 00889024505537
• UDI-Public: (01)00889024505537(17)281220(10)3189215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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 Model Number: N/A
• Device Catalogue Number: 47248605840
• Device Lot Number: 3189215
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male