MAUDE Adverse Event Report: Zimmer GmbH ANN BLUNT TIP SCREW 4X36MM; Implant, Trauma

Catalog Number	47248603640
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three proximal screws backed out approximately two weeks post-implantation.The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization.The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: ann blunt tip screw, #item 47248603640, #lot 3204743.Ann blunt tip screw, #item 47248603640, #lot 3250994.Ann ph nail , #item 47249620108, #lot 3216538.Therapy date: unknown.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.

• Brand Name: ANN BLUNT TIP SCREW 4X36MM
• Common Device Name: Implant, Trauma
• 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 ; +1(574)526-0384
• MDR Report Key: 50692617
• Report Number: 0009613350-2026-00451
• Device Sequence Number: 21236039
• Product Code: HSB
• UDI-Device Identifier: 00889024505421
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 47248603640
• Device Lot Number: 3263335
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 narrative.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown