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

Catalog Number AR-8936BC-CP

Device Problems Break (1069); Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (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 improper bone preparation, not inserting the implant co-axial to the bone tunnel and/or prying or leveraging while still loaded.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.Device was discarded by customer.

Event Description

It was reported that a brostrom repair implant system was used for a left anterior talo-fibular reconstruction procedure.The anchor was inserted.A second anchor was going to be inserted and the fibula pilot hole was drilled.As the anchor was being malleted in, the portion distal to the eyelet broke.The broken portion was flush with the cortical bone.The surgeon tied the first anchor and tested the strength of the insertion.As the second knot was tied, the first anchor pulled out of the bone.An incision was opened just distal to the fibula and a suture was used to perform the repair and complete the procedure.

• Brand Name: IMPLANT SYSTEM BROSTOM REPAIR
• Type of Device: FASTENER, FIXATION, BIO-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5666368
• MDR Text Key: 45504461
• Report Number: 1220246-2016-00230
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: AR-8936BC-CP
• Device Lot Number: 10012762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR