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	04/16/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the small ball at the end of the ar-9202-14 came off during removal of tsa stem.The surgery was completed and stem was able to be removed.
Additional Manufacturer Narrative
Complaint confirmed, the knob was found to have broken off from the head.The fragment was not returned, no measurement could be taken.The cause is undetermined, however likely causes include user-applied mechanical forces.

• 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: 11761159
• Report Number: 1220246-2021-02985
• Device Sequence Number: 1153803
• Product Code: LXH
• UDI-Device Identifier: 00888867058385
• UDI-Public: 00888867058385
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 06/23/2021

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: 250120305
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1