MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCH BIOCOMP SWI- VELOCK C CLD 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2324BCC

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

Patient Problem No Information (3190)

Event Date 07/24/2014

Event Type  Injury  

Event Description

It was reported that the swivelock broke during implantation in the tibia for back up fixation on a right acl reconstruction.It remained implanted and patient was not harmed.Follow-up information: it was stated that during the last turn of the of the driver, during implantation, the implant broke and the sutures pulled out.Since the partial implant was fully seated the doctor made the decision to leave the implant in place.There was no reported attempt made to remove the partial implant.The surgeon then moved to a slightly different location on the tibia and successfully implanted another implant to complete the case.The case was completed successfully and the patient was released as scheduled in stable condition.There was no report of any extra or enlarged incisions.

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 received and an evaluation was conducted.Device history record review revealed nothing relevant to this event.The evaluation of the returned device revealed that there was a broken portion of the peek eyelet attached to the suture and loaded into the driver square tip.The peek eyelet broke flush to the driver tip end while still loaded.Based on the evaluation, it can be confirmed that the peek eyelet broke approximately in half.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded or impacting the eyelet against hard bone.The directions for use warns: "attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during 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.

• Brand Name: SUTURE ANCH BIOCOMP SWI- VELOCK C CLD 4.75X19.1MM
• 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: 4019416
• MDR Text Key: 20976032
• Report Number: 1220246-2014-00140
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• 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: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 1185931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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