MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HIP FRACTURE NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	814611380
Medical Device Problem Codes	Fracture (1260); Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the ar drill misfired, hitting the nail and causing the drill bit to break.When drilling for the ar screw, the blue ar sheath was flush against the jig but the drill bit was not going through the hole in the nail.As a result, it was hitting the nail and misfiring.The sleeve was then removed, triple blue sleeve replaced and attempted to drill again but drill bit still hitting the nail and then broke off inside the patient.The tip of the ar drill was buried inside the greater troch and was unable to be removed.As a result, hardware retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 211201201; lot# cx2785m01.H6: proposed component code - mechanical (g04)- drill.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d1; d2; d4; d6a; d9; g1; g3; g4; g6; h1; h2; h4; h6.H6: proposed component code, mechanical (g04) nail.Customer has indicated that the nail will not be returned to zimmer biomet for investigation, as the product was implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d4; d9; g1; g3; g6; h1; h2; h4.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d4; d9; g1; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided or the nail; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the tip of a drill bit fragment is partially visualized in the proximal femoral metaphysis.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event for part 814611380.A definitive root cause cannot be determined.The event was confirmed.If any further information 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: AFFIXUS HIP FRACTURE NAIL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 5745260384
• MDR Report Key: 22860884
• Report Number: 0001825034-2025-02606
• Device Sequence Number: 7779363
• Product Code: HSB
• UDI-Device Identifier: 00887868567254
• UDI-Public: (01)00887868567254(17)350410(10)67088223
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2026

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: Health Professional
• Device Catalogue Number: 814611380
• Device Lot Number: 67088223
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 02/06/2026; 03/24/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 02/06/2026; 02/11/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female