MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; REVERSE SHOULDER, INSTRUMENTS

Catalog Number	110029132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the impactor broke during implant insertion.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item # 20809000902, comp aug rotate guide&bone rt, lot # 67998198; item # 20809000802, alliance glen guide & bone rgt, lot # 67998199; item # 406669, stn pn thd tip.125x2.5in 2pk, lot # 67632049; item # 405800, comp.Rev shldr 9 in steinmann, lot # 67826783; item # 405889, comp rvs 2.7mm dia drl, lot # 67839747; item # 110040202, compr aug 2.7 drill, lot # 67743906; item # 406669, stn pn thd tip.125x2.5in 2pk, lot # 67632056; item # 110032410, comp aug mini bsplt w tpr sm, lot # 67004796; item # 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 67627329; item # 180550, comp aug rotate guide&bone rt, lot # 67652823; item # 180550, comp aug rotate guide&bone rt, lot # 67730703; item # 180550, comp aug rotate guide&bone rt, lot # 67652836; item # 180550, comp aug rotate guide&bone rt, lot # 67730715; item # 115310, comp rvrs shldr glnsp std 36mm, lot # j8071646; item # 113632, comp primary stem 12mm mini, lot # 67706210; item # 110031399, hmrl tray std, lot # 67731025; item # 110031418, cr prolong 36mm brng std, lot # 67685371; product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: COMPR METAL IMPACTOR
• Common Device Name: REVERSE 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: 25234311
• Report Number: 0001825034-2026-01383
• Device Sequence Number: 10290207
• Product Code: KWS
• UDI-Device Identifier: 00887868470103
• UDI-Public: (01)00887868470103(11)231003(10)65699396
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 110029132
• Device Lot Number: 65699396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown