MAUDE Adverse Event Report: ARTHREX, INC. SUTURESNARE, 90 DEGREE STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number AR-6060-90

Device Problems Break (1069); Physical Resistance (2578); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/24/2017

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.Complainants event is typically caused by use of excessive force and/or prying/leveraging with the tip fully exposed on the device during use.This is the (b)(4) 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 procedure, the surgeon was attempting to use a 90° suture snare.He caught a suture with the snare and as he pulled, he felt resistance.He continued to pull and the tip of the wire broke off into the patient's joint.The surgeon attempted to retrieve the tip but was unsuccessful as he was unable to locate the tip.The fragment remained in patient body.The surgeon took a post-op x-ray however, the tip could not be seen.

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 due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The device met all material specification as received.The evaluation of the returned device revealed that the nitinol wire at the distal tip is broken off.Complainants event is typically caused by use of excessive force and/or prying/leveraging with the tip fully exposed on the device during use.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 procedure, the surgeon was attempting to use a 90° suture snare.He caught a suture with the snare and as he pulled, he felt resistance.He continued to pull and the tip of the wire broke off into the patient's joint.The surgeon attempted to retrieve the tip but was unsuccessful as he was unable to locate the tip.The fragment remained in patient body.The surgeon took a post-op x-ray however, the tip could not be seen.

• Brand Name: SUTURESNARE, 90 DEGREE STRAIGHT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 6571648
• MDR Text Key: 75316260
• Report Number: 1220246-2017-00172
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867204638
• UDI-Public: 00888867204638
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: AR-6060-90
• Device Lot Number: 10072434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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