MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALLIANCE GLENOID AUGMENT REAMER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED

Catalog Number	SBGL3705
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item# sbgl3004; lot# 64602123.Item# sbgl3005; lot# 64629321.Item# sbgl3704; lot# 64624282.H6: proposed component code - mechanical (g04) - drill.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a procedure, the size 4 & 5 glenoid reamers and 4 & 5 augment reamer were damaged due to the metal anchors in the glenoid.The reamers were grinded down from hitting the anchor.No patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.Visual examination of the returned product identified the four reamers show signs of use as well as wear and tear.The two glenoid reamers show damage to the cutting blades at the distal end of the devices.There are scratches along the shafts as well.Measured the heads of the glenoid reamers, devices were conforming.The two augment reamers have gouges to the cutting blades as well as scratches on the head.Measured the heads of the augment reamers, devices were conforming.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing for parts sbgl3004, sbgl3005, and sbgl3705.The root cause of the reported issue is attributed to use error.Per the ifu: do not subject instruments to high loads and/or impact; as the reamers were subjected to impact from hitting anchors that were already in the glenoid, the user did not follow instructions.The presence of the anchors should have been detected preoperatively as the alliance glenoid surgical technique, indicates prior to surgery, secure a/p and axial radiographs or an axial ct scan to fully assess the glenoid bone.The complaint was confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ALLIANCE GLENOID AUGMENT REAMER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22871650
• Report Number: 0001822565-2025-03036
• Device Sequence Number: 17593276
• Product Code: KWS
• UDI-Device Identifier: 00889024575189
• UDI-Public: (01)00889024575189(10)64626381
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K193180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: SBGL3705
• Device Lot Number: 64626381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Patient Age: 38 YR
• Patient Sex: Female