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

Catalog Number AR-2324BCC

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This is the first of two submissions for the same patient event.The other is 1220246-2016-00486 ((b)(4)).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.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 disposition unknown.

Event Description

It was reported to arthrex by the surgeon, via the arthrex surgical outcome system, that on (b)(6) 2016, a patient underwent a rotator cuff repair (ripstop fibertape with swivelock) using two ar-2324bcc, lot 10032194 ((b)(4)) and one ar-2324bcctt, lot 10023046 ((b)(4)).On (b)(6) 2016 the patient underwent a revision procedure because the patient was experiencing catching of the shoulder with internal rotation due to loose anchors in the sub-acromial space.The swivelock anchors were removed.No replacement anchors were used.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This is a follow-up submission to reflect device evaluation.This is the first of two submissions for the same patient event.The other is 1220246-2016-00486 ((b)(6)).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.Complaint confirmed.The device met all material specifications as received.The evaluation revealed two swivelock screws with damaged distal tips.On one of the screws the proximal end is damaged.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging during insertion, or improper bone preparation prior to 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.

Event Description

It was reported to arthrex by the surgeon, via the arthrex surgical outcome system, that on (b)(6) 2016, a patient underwent a rotator cuff repair (ripstop fibertape with swivelock) using two ar-2324bcc, lot 10032194 ((b)(6)) and one ar-2324bcctt, lot 10023046 ((b)(6)).On (b)(6) 2016, the patient underwent a revision procedure because the patient was experiencing catching of the shoulder with internal rotation due to loose anchors in the sub-acromial space.The swivelock anchors were removed.No replacement anchors were used.

• Brand Name: SUTURE ANCHOR, BIO-COMP. 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: 6085152
• MDR Text Key: 59351342
• Report Number: 1220246-2016-00485
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026827
• UDI-Public: 00888867026827
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 10032194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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