MAUDE Adverse Event Report: Zimmer Biomet, Inc. FIB ANATOMIC LOCK RT 4H STE; Plate, Fixation, Bone

Catalog Number	856207004
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial fixation procedure, a screw guide became stuck to the plate and the screwdriver tip fractured during attempted removal.To confirm the screw insertion direction, the guide had been reattached to the plate.When removal was attempted, the guide could not be released using a screwdriver.Increased force was applied, causing the screwdriver tip to break, with a fragment remaining inside the guide.The guide could not be removed, and the procedure was completed with the guide still attached to the plate.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item # 214215070, t-15 tapered driver, lot # rl303885.Item # unknown, unknown fast guide, lot # unknown.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.

• Brand Name: FIB ANATOMIC LOCK RT 4H STE
• Common Device Name: Plate, Fixation, Bone
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50506619
• Report Number: 0001825034-2026-02611
• Device Sequence Number: 21197134
• Product Code: HRS
• UDI-Device Identifier: 00887868445996
• UDI-Public: (01)00887868445996(17)350924(10)67503195
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 856207004
• Device Lot Number: 67503195
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female