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

Catalog Number AR-2324BSLM

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2016

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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Complainant's event typically caused by not inserting the implant co-axial to the bone tunnel, improper bone preparation and/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.Device requested but not yet received.

Event Description

It was reported that during a rotator cuff repair, the ar-2324bsl (bio-swivelock sp, 4.75 mm x 24.5 mm, self-punching) was used.The surgeon attempted to insert the anchor three times and on the third attempt the self punch tip and part of the swivelock anchor became implanted and could not be removed.The surgeon reported to the sales rep that what remained in the patient was secure.The surgeon was able to tie the suture from the anchor into the rotator cuff and bring the tendon down over the implanted anchor.Surgeon also placed another swivelock and incorporated it into the repair.Sales rep states it is unclear if the additional anchor was "buddied up" or placed close to the broken anchor.It was reported that the surgeon felt everything was secure.Case was completed as planned.No x-rays were taken.

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.This is a follow-up submission to reflect device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The device met all material specification as received.The evaluation revealed that the anchor's distal tip is broken off.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 during a rotator cuff repair, the ar-2324bsl (bio-swivelock sp, 4.75 mm x 24.5 mm, self-punching) was used.The surgeon attempted to insert the anchor three times and on the third attempt the self punch tip and part of the swivelock anchor became implanted and could not be removed.The surgeon reported to the sales rep that what remained in the patient was secure.The surgeon was able to tie the suture from the anchor into the rotator cuff and bring the tendon down over the implanted anchor.Surgeon also placed another swivelock and incorporated it into the repair.Sales rep states it is unclear if the additional anchor was "buddied up" or placed close to the broken anchor.It was reported that the surgeon felt everything was secure.Case was completed as planned.No x-rays were taken.

• Brand Name: SUTURE ANCHOR BIO-SWIVELOCK
• 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: 6000519
• MDR Text Key: 56536979
• Report Number: 1220246-2016-00413
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026896
• UDI-Public: 00888867026896
• 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,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: AR-2324BSLM
• Device Lot Number: 1184036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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