MAUDE Adverse Event Report: ZIMMER GMBH ANN PH NAIL RT 9X160MM; Rod, Fixation, Intramedullary And Accessories

Catalog Number	47-2496-160-09
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Aseptic loosening (4883)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: desc: ann blunt tip screw 4x44mm; item: 47-2486-044-40; lot: 3265431.G2: report source: spain.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 from a clinical study that a patient had underwent im nailing of the right proximal humerus.Subsequent x-rays revealed evidence of proximal screw loosening and protrusion.The patient is scheduled for screw removal on an unknown date due to pain from the protruded screw.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• 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 8404 ; SZ 8404
• 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: 25025527
• Report Number: 0009613350-2026-00229
• Device Sequence Number: 15998981
• Product Code: HSB
• UDI-Device Identifier: 00889024505780
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 47-2496-160-09
• Device Lot Number: 3223706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 209 LB