MAUDE Adverse Event Report: ZIMMER GMBH ANN BLUNT TIP SCREW 4X46MM; IMPLANT, TRAUMA

Catalog Number	47248604640
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial surgery and subsequently required a reoperation approximately 3 months post-implantation due to proximal screw backout associated with pain.During follow-up approximately 3 months after the initial procedure, the surgeon noted that proximal screws in positions #1 and #3 had backed out of their proper position.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: ann ph nail rt 10x200 mm, #item 47249620009, #lot 3189233; ann blunt tip screw 4x40 mm, #item 47248604040, #lot unk.Therapy date: (b)(6) 2026.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 4X46MM
• 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 ; 5745260384
• MDR Report Key: 25363413
• Report Number: 0009613350-2026-00286
• Device Sequence Number: 9847464
• Product Code: HSB
• UDI-Device Identifier: 00889024505476
• UDI-Public: (01)00889024505476(17)300528(10)3241530
• 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
• Device Explanted 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): 06/02/2026

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: 47248604640
• Device Lot Number: 3241530
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown