MAUDE Adverse Event Report: ARTHREX, INC. 10 MM SINGLE USE OATS SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10 MM SINGLE USE OATS SET
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery with an osteochondral autograft transfer system the tip of the recipient set has loosened, preventing the preparation of the healthy core recipient site.The broken fragments were removed from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-1981-08s + ar-1981-06s).It was not necessary to switch the surgical technique or do a second surgery.
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.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1981-10s was received for investigation.Visual inspection identified that the ar-1981cp-10r recipient collared pin had broken at the weld between the head and the shaft.The shaft was retained within remnants of bone inside the distal end of the recipient handle assembly.The diameter of the shaft was assessed using digital micrometer id: (b)(4) , and was determined to meet design specifications.Damage was present along the edges of the broken pin head.The cause remains undetermined.The bone quality encountered during the procedure was not provided.

• Brand Name: 10 MM SINGLE USE OATS SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12737877
• Report Number: 1220246-2021-03866
• Device Sequence Number: 4788135
• Product Code: LXH
• UDI-Device Identifier: 00888867025356
• UDI-Public: 00888867025356
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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 Expiration Date: 03/31/2026
• Device Model Number: 10 MM SINGLE USE OATS SET
• Device Catalogue Number: AR-1981-10S
• Device Lot Number: 1075110868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown