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

Catalog Number AR-2324BSLC

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/23/2015

Event Type  Injury  

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.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 typically caused by not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is 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.

Event Description

It was reported that a vented bio-swivelock device was used for a right shoulder rotator cuff repair procedure.While inserting the posterior-lateral anchor using a speedbridge technique "the top portion of the anchor sheared off, a very clean sharp break as if the torque of the insertion/bone interface halted the bottom half of the anchor from turning".Two threads length of the proximal aspect of the anchor remained on the driver shaft of the device.The other 3/4 portion of the anchor remained in the patient.The surgeon attempted to remove the distal portion of the anchor from the patient by pulling on the implanted portion with more force than normal and the anchor did not come loose.The surgeon left the 3/4 portion in the patient.The anchor was flush with the cortex.Sales rep states the surgeon felt the implanted portion was secure and proceeded with the repair.To complete the procedure the surgeon decided to tap the remaining anterio-lateral hole to avoid a repeat situation.Patient bone was very hard.The top portion of the anchor that sheared off was discarded by the facility.There were no unplanned incisions and no extra anchors used as a result of this incident.

• Brand Name: SUTURE ANCHOR, BIO-SWVLK C.
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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: 5298629
• MDR Text Key: 33545605
• Report Number: 1220246-2015-00351
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K101823
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: AR-2324BSLC
• Device Lot Number: 1238573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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