MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-COMP PUSHLOCK, 2.9 X 12.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2923BC

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2014

Event Type  Injury  

Event Description

It was reported that during a labral repair procedure, two implants broke at the eyelet on insertion.Both times as the surgeon inserted the anchors into the pre-drilled holes, the eyelets cracked.The sutures and eyelets pulled away from the inserter allowing the implants to come off the inserter and slide-off the glenoid into the posterior labral soft tissue.The surgeon tried to locate the implants but could not.He then re-drilled a 3rd hole and inserted a 3.5 pushlock to complete the repair.

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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.This is the first complaint of this type for this part/lot combination.Device was discarded by the facility.

• Brand Name: SUTURE ANCHOR, BIO-COMP PUSHLOCK, 2.9 X 12.5MM
• 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: 3699808
• MDR Text Key: 4230100
• Report Number: 1220246-2014-00043
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101679
• 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: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Catalogue Number: AR-2923BC
• Device Lot Number: 822141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: 35 YR