MAUDE Adverse Event Report: ZIMMER GMBH BLUNT TIP SCREW, ÿ 4X48MM; IMPLANT, TRAUMA

Catalog Number	47-2486-048-40
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an initial clavicle plating for fracture completed.The patient reported persistent pain and stiffness after surgery at around 9 months post-op and the fracture was observed to be consolidated in good position so device removal was recommended.On imaging nail protrusion was noted.The device removal procedure was completed on one year post implantation without any known complications.Further details have not been provided.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: proximal humerus, left, #item 47249616107, #lot 3163113.Proximal humerus nail cap, #item 47248801000, #lot 3208165.Blunt tip screw, item #47248604640, #item 3207879.Blunt tip screw, #item 47248604440, #lot 3202505.Cortical bone screw, #item 47248613040, #lot 3197007.Cortical bone screw, #item 47248613240, #lot 3183248.Therapy date: (b)(6) 2025.G2: country report source: spain.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6.The cmp was confirmed.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.The reported products were reviewed for compatibility with no issues noted.Review of the complaint history found no additional related complaints for the nail item and the reported part and lot combination.Review of the complaint histories for the screws and cap 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.Medical records were provided and reviewed by a health care professional.The review identified that patient had an initial right alps clavicle system implanted.Subsequently, the patient experienced a rotator cuff with failed repairment 1 year later.Patient reported pain and stiffness.The deltoid insertion was painful.The radiographs showed no displacement.Fracture was consolidated in good position.The nail protrudes next to a screw.Patient was transfered to emergency after falling on the ground.Nail, cap and screws were removed.Review of medical records identified seizure with fall as contributing factor to the event.A definitive root cause could not be determined.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
No further information is available at the time of this report.

• Brand Name: BLUNT TIP SCREW, ÿ 4X48MM
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23497430
• Report Number: 0009613350-2025-00867
• Device Sequence Number: 8992484
• Product Code: HSB
• UDI-Device Identifier: 00889024505483
• UDI-Public: (01)00889024505483(17)290606(10)3205625
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K231114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 04/21/2026

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 Catalogue Number: 47-2486-048-40
• Device Lot Number: 3205625
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 68 KG