MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCH BIOCOMP CORK SCREW FT VNTD 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1927BCNF

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/15/2014

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 partial device was received and an evaluation was conducted.The complaint was not confirmed.Device history record review revealed nothing relevant to this event.The returned device consisted of the driver and sutures only.Pieces of the implant were not returned for evaluation.A definitive cause of the event could not be determined without device evaluation.However, based on the event description the complainant's event was most likely caused by not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded, over-insertion, improper bone preparation or insertion into hard bone.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 Description

It was reported that the anchor broke at the tip during insertion and was not retrieved.There was no bone preparation.Shoulder repair procedure.

• Brand Name: SUTURE ANCH BIOCOMP CORK SCREW FT VNTD 5.5X14.7MM
• 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: 4022529
• MDR Text Key: 16946021
• Report Number: 1220246-2014-00145
• 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,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2014
• Device Catalogue Number: AR-1927BCNF
• Device Lot Number: 538947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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: 51