MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP. REV SHLDR 9 IN STEINMANN; SHOULDER, INSTRUMENTS

Catalog Number	405800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item # ab-150t-1b, activbrd 1.5 tape bl tpr ndl, lot # 2304772.Item # ab-150t-1w, activbrd 1.5 tape w/bk tpr ndl, lot # 2307584.Item # 405889, comp rvs 2.7mm dia drl, lot # 67480037.Item # 180550, comp lk scr 3.5hex 4.75x15 st, lot # 67561784.Item # 180550, comp lk scr 3.5hex 4.75x15 st, lot # 67538906.Item # 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 67512281.Item # 115310, comp rvrs shldr glnsp std 36mm, lot # j7996609.Item # 110032410, comp aug mini bsplt w tpr sm, lot # 67418534.Item # 180551, comp lk scr 3.5hex 4.75x20 st, lot # 67420992.Item # 180554, comp lk scr 3.5hex 4.75x35 st, lot # 67391451.Item # 405800, comp.Rev shldr 9 in steinmann, lot # 67631917.Item # sahs1106, humeral stem standard size 6, lot # 66775286.Item # sahtnem6, humeral tray neutral -6mm ext, lot # 67609708.Item # 110031418, cr prolong 36mm brng std, lot # 67561275.Item # sahs1105, humeral stem standard size 5, lot # 67436256.Item # sahtnem6, humeral tray neutral -6mm ext, lot # 67529689.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.
Event or Problem Description
It was reported that the tip of a steinmann pin broke off.Attempts have been made and no further information has been provided.

• Brand Name: COMP. REV SHLDR 9 IN STEINMANN
• Common Device Name: SHOULDER, INSTRUMENTS
• 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: 24583058
• Report Number: 0001825034-2026-00579
• Device Sequence Number: 10391692
• Product Code: FZX
• UDI-Device Identifier: 00887868504563
• UDI-Public: (01)00887868504563(17)360121(10)67770875
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405800
• Device Lot Number: 67770875
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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.
• Patient Sex: Female