MAUDE Adverse Event Report: Zimmer GmbH ANN CORT BONE SCREW 4 X 24MM; Prosthesis, Shoulder

Catalog Number	47-2486-124-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bursitis (4832)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinical study reported that the patient underwent an initial left humerus open reduction and internal fixation.Subsequently the patient received a steroid injection for subacromial bursitis.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: item: 47-2496-261-08 - ann ph nail lt 8.5x260mm - lot: 3234394.Item: 47-2486-040-40 - ann blunt tip screw 4x40mm - lot: 3271782.Item: 47-2486-140-40 - ann cort bone screw 4 x 40mm - lot: 3212554.Item: 47-2486-124-40 - ann cort bone screw 4 x 24mm - lot: 3196229.Item: 47-2486-126-40 - ann cort bone screw 4 x 26mm - lot: 3244433.G2: report source: europe: belgium.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 CORT BONE SCREW 4 X 24MM
• Common Device Name: Prosthesis, Shoulder
• 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: 50340469
• Report Number: 0009613350-2026-00428
• Device Sequence Number: 5750502
• Product Code: HSB
• UDI-Device Identifier: 00889024505322
• UDI-Public: (01)00889024505322(17)300526(10)3241538
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47-2486-124-40
• Device Lot Number: 3241538
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2025
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 234 LB