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	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
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.
Event or Problem Description
It was reported that the surgeon malleted the recipient oats into the femoral condyle.He was having a hard time going in so he malleted a little harder.Once he got to the appropriate level, he followed the technique to pull the plug out and half of the bone plug came out.When he looked at the tip of the recipient harvester, he noticed half of the tip was beveled.This caused the hole to be larger than the donor graft.To complete the procedure the surgeon had to improvise.Surgeon placed the plug in and filled bone matrix around the edge and covered with the seal.
Additional Manufacturer Narrative
Complaint confirmed, the cutting edge is damaged, with a section cracked and bent outward.There is excessive wear and tear on the device indicative of multiple of uses.A likely cause of the event is hitting the cutting edge of device with another object.

• 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
• MDR Report Key: 10159927
• Report Number: 1220246-2020-01899
• Device Sequence Number: 14249186
• Product Code: LXH
• UDI-Device Identifier: 00888867025356
• UDI-Public: 00888867025356
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 08/31/2024
• Device Model Number: 10 MM SINGLE USE OATS SET
• Device Catalogue Number: AR-1981-10S
• Device Lot Number: 925597131
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other