MAUDE Adverse Event Report: ZIMMER GMBH ANN PH NAIL RT 10X220MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	47-2496-220-09
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: desc: ann blunt tip screw 4x40mm; item: 47-2486-040-40; lot: 3225544.Desc: ann blunt tip screw 4x42mm; item: 47-2486-042-40; lot: 3237315.Desc: ann blunt tip screw 4x46mm; item: 47-2486-046-40; lot: 3241530.Desc: ann cort bone screw 4 x 28mm; item: 47-2486-128-40; lot: 3242891.Desc: ann cort bone screw 4 x 28mm; item: 47-2486-128-40; lot: 3242891.Desc: affixus ph nl cap 0mm; item: 47-2488-010-00; lot: 3242900.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 the patient underwent an initial procedure with an intramedullary nail, after which one proximal screw backed out approximately 2 weeks postoperatively.The patient remained under clinical observation and no revision has been planned to date.Attempts have been made and no further information has been provided.

• Brand Name: ANN PH NAIL RT 10X220MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 24176236
• Report Number: 0009613350-2026-00024
• Device Sequence Number: 9569784
• Product Code: HSB
• UDI-Device Identifier: 00889024505919
• UDI-Public: (01)00889024505919(17)340607(10)3204819
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47-2496-220-09
• Device Lot Number: 3204819
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: Male