MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1934BCF

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/26/2014

Event Type  Injury  

Event Description

It was reported in a maude review that the implant snapped off.The surgeon ordered a fluoro x-ray.They were unable to remove the broken implant.

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.An foia request (b)(4) was made but subsequently denied.Lot number was not provided so device history record review cannot be performed.The device was not returned so 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.If additional relevant information is received, a follow-up report will be submitted.Complainant's event is typically caused by improper bone prep, over-insertion, not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4263879
• MDR Text Key: 15114857
• Report Number: 1220246-2014-00231
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-1934BCF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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