MAUDE Adverse Event Report: ZIMMER GMBH ANN PH NAIL LT 9X160MM; HUMERUS INTRAMEDULLARY NAIL

Catalog Number	47-2496-161-09
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).: d10: 47-2486-036-40; ann blunt tip screw 4x36mm; (b)(6).47-2486-038-40; ann blunt tip screw 4x38mm; (b)(6).47-2486-038-40; ann blunt tip screw 4x38mm; (b)(6).47-2486-050-40; ann blunt tip screw 4x50mm; (b)(6).47-2486-124-40; ann cort bone screw 4 x 24mm; (b)(6).47-2486-124-40; ann cort bone screw 4 x 24mm; (b)(6).47-2488-010-00; affixus ph nl cap 0mm; (b)(6).G2: report source: 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
It was reported that an initial operation was performed with ann nail.Subsequently, a proximal screw was observed to have backed out approximately 2 weeks postoperatively.The patient will be monitored and no revision surgery has be planned so far.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h6, h10, h11.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 product combination was approved by zimmer biomet.The surgical technique explains that the locking of the corelock is done using the corelock driver with torque limiting handle."turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle.Review of the complaint history/histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Complaints are monitored in order to identify potential adverse trends.A definitive root cause could not be performed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ANN PH NAIL LT 9X160MM
• Common Device Name: HUMERUS INTRAMEDULLARY NAIL
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23568229
• Report Number: 0009613350-2025-00881
• Device Sequence Number: 21375537
• Product Code: HSB
• UDI-Device Identifier: 00889024505810
• UDI-Public: (01)00889024505810(17)350824(10)3239025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 47-2496-161-09
• Device Lot Number: 3239025
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Male