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

Catalog Number	AR-6060-90
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The most likely cause of this type of event is the 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.Risk manager will not release device.
Event or Problem Description
It was reported that during a left rotator cuff repair procedure, while the surgeon was passing the suture, the tip of the 90° straight suture snare, ar-6060-90, broke off.The tip was retrieved with graspers and a second 90° straight suture snare of the same lot was opened and again, as the surgeon was attempting to pass the suture, the tip of the device broke-off into the patient.This time, the surgeon was unable to locate the tip and an x-ray was brought in to confirm that the tip was still inside of the patient.After an hour and a half of attempting to retrieve the broken tip the surgeon completed the case with the tip still inside the patient.Incident resulted in a 1.5 hour delay in case.
Additional 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.Complaint confirmed.The evaluation of the returned devices revealed that the nitinol wires at the distal tips are broken off.The most likely cause of this type of event is the 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 or Problem Description
It was reported that during a left rotator cuff repair procedure, while the surgeon was passing the suture, the tip of the 90° straight suturesnare, ar-6060-90, broke off.The tip was retrieved with graspers and a second 90° straight suture snare of the same lot was opened and again, as the surgeon was attempting to pass the suture, the tip of the device broke-off into the patient.This time, the surgeon was unable to locate the tip and an x-ray was brought in to confirm that the tip was still inside of the patient.After an hour and a half of attempting to retrieve the broken tip the surgeon completed the case with the tip still inside the patient.Incident resulted in a 1.5 hour delay in case.

• Brand Name: SUTURESNARE, 90 DEGREE STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6394906
• Report Number: 1220246-2017-00064
• Device Sequence Number: 975927
• Product Code: LXH
• UDI-Device Identifier: 00888867204638
• UDI-Public: 00888867204638
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: AR-6060-90
• Device Lot Number: 10058627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other