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

Catalog Number	AR-1981-10S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The evaluation revealed that the returned device's tip is slight dented.The tip wall thickness dimension is within specification.Lot number was not provided so device history record review cannot be performed.Complainant's event typically caused by not positioning the harvester's sharp edges perpendicular to the bone surface before malleting into the bone.
Event or Problem Description
It was initially reported that the harvester failed to cut and pull out the donor bone during oats/ankle case.Additional information received 10/20/2016: two instruments (recipient and donor harvester) composed of 10mm single use oats failed so it couldn't remove (tear off) bone block.The procedure was switched with cutting tools like burr and shaver hand-piece were used during the operation to finish the surgery.The instrument being returned from oats set ar-1981-10s is ar-1981sa-10d lot 67251515.

• Brand Name: OATS SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6085160
• Report Number: 1220246-2016-00492
• Device Sequence Number: 16332983
• Product Code: LXH
• UDI-Device Identifier: 00888867025356
• UDI-Public: 00888867025356
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/20/2016

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 Catalogue Number: AR-1981-10S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other