MAUDE Adverse Event Report: ARTHREX, INC. OSTEOCON FLAP REPR SINGSHOT INST; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OSTEOCON FLAP REPR SINGSHOT INST
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	05/23/2019
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 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 during an osteochondral repair procedure, the single shot spear and drill was used to insert the first chondral dart successfully.A second location was chosen and the single shot spear and drill were used.When the drill collar contacted the back of the spear, the collar sheared off the drill shaft.The procedure then had to be converted from an arthroscopy to arthrotomy.The incision was extended and the affected cartilage was removed and chondral drilling of the defect carried out.

• Brand Name: OSTEOCON FLAP REPR SINGSHOT INST
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8711853
• Report Number: 1220246-2019-01153
• Device Sequence Number: 19499017
• Product Code: LXH
• UDI-Device Identifier: 00888867031272
• UDI-Public: 00888867031272
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/19/2019

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: 12/31/2023
• Device Model Number: OSTEOCON FLAP REPR SINGSHOT INST
• Device Catalogue Number: AR-4009S
• Device Lot Number: 10269061
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/19/2019
• 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