MAUDE Adverse Event Report: ZIMMER GMBH NCB SCR I4.0 SELF-TAPPING 55MM; IMPLANT, TRAUMA

Catalog Number	02.02155.055
Medical Device Problem Codes	Biocompatibility (2886); Migration (4003)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Ulcer (2274)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an ankle arthrodesis procedure on an unknown date using screws.Following surgery, exudate was observed around the 6.5 mm cannulated compression screw incision site with elevated c-reactive protein levels, and infection was initially suspected.After antibiotic administration, the c-reactive protein decreased; however, an ulcer subsequently developed at the incision site.Imaging studies suggested bone resorption.Consequently, approximately two months postoperatively, all screws were removed due to suspected loss of fixation strength and a possible metal allergy.The patient underwent screw removal; no further information regarding the patient¿s condition following the procedure was provided.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10.6.5x45mm cann canc scr 22 item# 1419645 lot# 582745.6.5x50mm cann canc scr 22 item# 14196-50 lot# dfmb7t.6.5x60mm cann canc scr 22 item# 14196-60 lot# m08335f.4.0 cann canc lag scr 55mm item# 1437655 lot# m26831a.G2: foreign - event occurred in japan.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
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, h11.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; a product evaluation could not be performed.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.

• Brand Name: NCB SCR I4.0 SELF-TAPPING 55MM
• 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: 23414980
• Report Number: 0009613350-2025-00836
• Device Sequence Number: 10269057
• Product Code: HRS
• UDI-Device Identifier: 00889024291539
• UDI-Public: (01)00889024291539(17)280822(10)3169160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/31/2026

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: 02.02155.055
• Device Lot Number: 3169160
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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 Sex: Male