MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a univers reverse surgery a metal piece of the trial implant broke off.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, a piece of metal was found inside ø.1260.According to drawing 1002112 rev 0, no metal part is a component of the device.Also, it noted that the edges around the arthrex® univers revers¿ trial glenosphere 42 + 2.5 inf had broken off.-functional testing was not performed due to the damage to the device.The failure is most likely due to wear and tear from repeated use of a mating part.Manufacturing date 2012.

• Brand Name: UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19067232
• Report Number: 1220246-2024-01888
• Device Sequence Number: 6593246
• Product Code: LXH
• UDI-Device Identifier: 00888867062221
• UDI-Public: 00888867062221
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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 Model Number: UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF
• Device Catalogue Number: AR-9540MD-02
• Device Lot Number: 250120600
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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