MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, BIO-COMP ACHILLES SPEEDBRIDGE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-8928BC-CP
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, 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 device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel or improper bone preparation prior to insertion.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.Portion remains in patient.
Event or Problem Description
It was reported that during an achilles tendon repair on (b)(6) 2016, the surgeon was attempting to insert the fourth ar-8928bc-cp, swivelock.During insertion, the anchor split down the middle.About 5mm of the anchor broke and was removed from the patient.The surgeon had used the tap from the achilles speed bridge.The seated depth of the remainder of the implant was about 3/4 and the surgeon was happy with the fixation the remaining portion of the anchor provided.No patient injury.Bone quality was reported to be average.

• Brand Name: IMPLANT SYSTEM, BIO-COMP ACHILLES SPEEDBRIDGE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6180330
• Report Number: 1220246-2016-00583
• Device Sequence Number: 828156
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

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 Expiration Date: 08/01/2018
• Device Catalogue Number: AR-8928BC-CP
• Device Lot Number: 10061946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/16/2016
• 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