MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, ARTHREX BROSTOM REPAIR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-8936BC-CP
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 drill's distal tip is broken-off.The sheared tip portion was not returned for evaluation.The device met all material specification as received.Device history record review revealed nothing relevant to this event.The complainant's event is typically caused by user mechanical damage from dropping the device or hitting the device against another device.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the arthrex brostrom repair implant system was being used in a brostom repair procedure.While using the cannulated drill that is included in the kit to drill a bone tunnel, the tip of the drill broke off.The tip of the drill bit was pulled out of the posterior aspect of the fibula when doing peroneal tendon repair as adjunct to lateral ankle stabilization.The second incision was extended slightly to get access to where the drill tip was in order to remove it.No broken pieces remain in the patient.A second arthrex brostom repair implant system was opened to complete the procedure successfully.No patient injury reported.

• Brand Name: IMPLANT SYSTEM, ARTHREX BROSTOM REPAIR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6394887
• Report Number: 1220246-2017-00060
• Device Sequence Number: 13461889
• Product Code: MAI
• UDI-Device Identifier: 00888867051263
• UDI-Public: 00888867051263
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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: 09/01/2018
• Device Catalogue Number: AR-8936BC-CP
• Device Lot Number: 10080035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/10/2017
• 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
• Patient Age: 38 YR
• Patient Weight: 157