MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP. REV SHLDR 9 IN STEINMANN; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	405800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that when inserting the central guide pin into the glenoid the threads broke off and stayed in the patient's bone.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a3; a3; b4; b5; d2; d4; d5; g1; g3; g6; h1; h2; h3; h4; h6.The reported event is confirmed as x-rays were provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right shoulder arthroplasty.Retained fractured pin fragment within the glenoid.A definitive root cause cannot be determined.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP. REV SHLDR 9 IN STEINMANN
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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 ; 5745260384
• MDR Report Key: 21690491
• Report Number: 0001825034-2025-00829
• Device Sequence Number: 8849730
• Product Code: FZX
• UDI-Device Identifier: 00887868504563
• UDI-Public: (01)00887868504563(17)350205(10)67146811
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 67146811
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male