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

Model Number	UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
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 during a surgery the device broke inside the patient.No broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.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.Update 25-oct-2021: it was confirmed that the threaded tip of the device broke off.Update 27-oct-2021: the actually affected device is the ar-9511 (lot: 051849).
Additional Manufacturer Narrative
Complaint confirmed, the threaded tip of the pin broke off.The fragment was not returned, as such no relevant features could be measured.No damage further was observed on the block or threaded pin.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
• 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: 12770443
• Report Number: 1220246-2021-03889
• Device Sequence Number: 4639086
• Product Code: MDM
• UDI-Device Identifier: 00888867061828
• UDI-Public: 00888867061828
• 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): 11/18/2021

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 REVS STEM/CUP EXTRACT ADPTR HNDL
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown