MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4 PEG MOD GLEN TRIAL SZ 4; PROSTHESIS, SHOULDER

Catalog Number	SBGL6044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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 the glenoid trial had 1 peg missing out of the 3 pegs.No adverse event has been reported as a result of the malfunction.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified one of the pegs is fractured and missing. wear & tear is seen which indicates repeated use.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: 4 PEG MOD GLEN TRIAL SZ 4
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 18033347
• Report Number: 0001825034-2023-02512
• Device Sequence Number: 17947480
• Product Code: KWS
• UDI-Device Identifier: 00889024574830
• UDI-Public: (01)00889024574830(11)201028(10)64927028
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: SBGL6044
• Device Lot Number: 64927028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown