MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR GLENOID TRIAL 4 PEG SIZE 2; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	SBGL6042
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a device fractured while being impacted during a shoulder procedure.However, no health consequences or impact to the patient were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.
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 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.Zimmer biomet will continue to monitor for trends.
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.Visual examination of the returned product identified the product is cracked and exhibits signs of repeated use.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to use error.The surgical technique indicates to use the glenoid inserter to place the glenoid trial into the bone.It was reported that the trial was impacted.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: MODULAR GLENOID TRIAL 4 PEG SIZE 2
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 16544816
• Report Number: 0001822565-2023-00695
• Device Sequence Number: 6520986
• Product Code: KWS
• UDI-Device Identifier: 00889024574816
• UDI-Public: (01)00889024574816(11)210413(10)65086886
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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: SBGL6042
• Device Lot Number: 65086886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/19/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 05/04/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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
• Patient Sex: Unknown