MAUDE Adverse Event Report: ZIMMER GMBH ANN PH NAIL RT 9X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	47249616009
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10.Ann ph nail rt 9x160mm item# 47249616009 lot# 3239977.Blunt tip screw, ã¿ 4x38mm item# 47248603840 lot# 3245964.Blunt tip screw, ã¿ 4x40mm item# 47248604040 lot# 3251019.Cortical bone screw, ã¿ 4x26mm item# 47-2486-126-40 lot# 3237321r.Cortical bone screw, ã¿ 4x26mm item# 47248612640 lot# 3245444.Washer small (x2) item# 47248800004 lot# 3238847.Proximal humerus nail cap, 0mm item# 47248801000 lot# 3241558.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
It was reported that one proximal screw backed out approximately 2 months postoperatively following an intramedullary nailing procedure.The patient was monitored, and no revision was planned.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: ANN PH NAIL RT 9X160MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 24274669
• Report Number: 0009613350-2026-00040
• Device Sequence Number: 10669707
• Product Code: HSB
• UDI-Device Identifier: 00889024505780
• UDI-Public: (01)00889024505780(17)350609(10)3239977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K231114
• 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): 07/09/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47249616009
• Device Lot Number: 3239977
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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: Unknown