MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL PROTECTOR S; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNIVERS REVERS HUMERAL PROTECTOR S
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-9509-s arthrex univers revers humeral protector was left in the patient during a tsa procedure.This was discovered during a post-operation visit, via x-ray.Revision surgery has been scheduled to remove the protector, but exact date is unknown.
Event or Problem Description
On 11/09/2022, it was reported by a sales representative via sems that an ar-9509-s arthrex univers revers humeral protector was left in the patient during a tsa procedure.This was discovered during a post-operation visit, via x-ray.Revision surgery has been scheduled to remove the protector, but exact date is unknown.Additional information received on 12/16/2022: original procedure took place on (b)(6) 2022.On (b)(6) 2022, during the post-operation visit, the x-ray confirm the protector was left inside.Revision procedure occurred on (b)(6) 2022.Both surgeries were performed by the same surgeon and at the same facility.Only the protector was removed during the revision surgery.
Additional Manufacturer Narrative
The complaint is confirmed.The probable cause of the event could not be determined from the information available; however, a most likely cause is customer misuse.

• Brand Name: UNIVERS REVERS HUMERAL PROTECTOR S
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15923926
• Report Number: 1220246-2022-05892
• Device Sequence Number: 6793876
• Product Code: LXH
• UDI-Device Identifier: 00888867061606
• UDI-Public: 00888867061606
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UNIVERS REVERS HUMERAL PROTECTOR S
• Device Catalogue Number: AR-9509-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown