MAUDE Adverse Event Report: ARTHREX, INC. SMALL JOINT OATS SET, 10 MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	SMALL JOINT OATS SET, 10 MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a sj oats (talus defect) a smalljoint oats 10 mm was used, it does not work when the condyle is removed, so the punching at the knee remains defective.There was no harm for the patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update 13sep2018: after consultation with the doctor, the punched but not used cylinder is a defect that becomes scarred but has damaged the cartilage.Further, another cylinder had to be punched, which could not be removed at the optimal position, so that the cartilage replacement at the talus was not completely flush.These two aspects are to the disadvantage of the patient.

• Brand Name: SMALL JOINT OATS SET, 10 MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7923102
• Report Number: 1220246-2018-00683
• Device Sequence Number: 1400163
• Product Code: MDM
• UDI-Device Identifier: 00888867056831
• UDI-Public: 00888867056831
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: SMALL JOINT OATS SET, 10 MM
• Device Catalogue Number: AR-8981-10S
• Device Lot Number: 730778576
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other