MAUDE Adverse Event Report: ARTHREX, INC. UNI REV HUMERAL RESECTION GUIDE 135/155; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNI REV HUMERAL RESECTION GUIDE 135/155
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
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 univers revers shoulder surgery wires got stuck in the holes of the device and broke off.No broken parts were loose inside the patient and had to be retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully by sawing freehand.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed, the ar-9507rgdp-3 device was returned with two broken pins, stuck in two of the ø.096 in holes.The available holes were found to meet specifications.The pins remain unidentified and do not match the drill tip features of 2.4 mm osteotomy guide pins required per surgical technique.Further information provided indicated the pins used are 2.5 mm pins from another manufacturer which are not designed to be used on the ar-9507rgp-3.The cause of the event is thus not following surgical technique.

• Brand Name: UNI REV HUMERAL RESECTION GUIDE 135/155
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12231939
• Report Number: 1220246-2021-03449
• Device Sequence Number: 17391231
• Product Code: LXH
• UDI-Device Identifier: 00888867266025
• UDI-Public: 00888867266025
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: UNI REV HUMERAL RESECTION GUIDE 135/155
• Device Catalogue Number: AR-9507RGDP-3
• Device Lot Number: 051921
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1