MAUDE Adverse Event Report: Zimmer Biomet, Inc. Comprehensive® Reverse Shoulder; shoulder prosthesis, reverse configuration

Catalog Number	405800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a left reverse total shoulder arthroplasty, a threaded steinmann pin fractured off in the patient.Surgical technique was reported as used, with no deviation from the described surgical technique.Patient conditions/anatomy were reported as not contributing to the event.No medical or surgical intervention, no surgical delay, and no surgical complication were reported in connection with the event aside from the malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).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: Comprehensive® Reverse Shoulder
• Common Device Name: shoulder prosthesis, reverse configuration
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50515074
• Report Number: 0001825034-2026-02614
• Device Sequence Number: 9310171
• Product Code: PHX
• UDI-Device Identifier: 00887868504563
• UDI-Public: (01)00887868504563(17)260529(10)68007468
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/30/2026

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: Health Professional
• Device Catalogue Number: 405800
• Device Lot Number: 68007468
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female