MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS STEM/CUP INSERTR IMPACTOR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	UNIVERS REVS STEM/CUP INSERTR IMPACTOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/22/2022 it was reported by a sales representative via sems that an ar-9511 impactor broke.This was discovered during use in a procedure on (b)(6) 2022.The break happened during extraction of stem and suture cup, the adapter malfunctioned and snapped.No fragments in patient, surgery not impacted.
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.

• Brand Name: UNIVERS REVS STEM/CUP INSERTR IMPACTOR
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 14075132
• Report Number: 1220246-2022-04720
• Device Sequence Number: 20035644
• Product Code: MDM
• UDI-Device Identifier: 00888867061828
• UDI-Public: 00888867061828
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/11/2022

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 STEM/CUP INSERTR IMPACTOR
• Device Catalogue Number: AR-9511
• Device Lot Number: 051849
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/11/2022
• Date Device Manufactured: 03/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown