MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS SLAP HAMMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNIVERS SLAP HAMMER
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported during a shoulder arthroplasty revision procedure that the ar-9202-14 slap hammer broke while trying to extract an implant.Another ar-9202-14 was opened and used to complete the procedure.The date of the primary total shoulder arthroplasty surgery is unknown.The rep stated the reason for the revision surgery was for a rotator cuff arthroplasty.The part and lot numbers of explanted product is unknown.All explanted material was discarded.

• Brand Name: UNIVERS SLAP HAMMER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11687036
• Report Number: 1220246-2021-02904
• Device Sequence Number: 17301922
• Product Code: LXH
• UDI-Device Identifier: 00888867058385
• UDI-Public: 00888867058385
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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 SLAP HAMMER
• Device Catalogue Number: AR-9202-14
• Device Lot Number: 1498031700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1