MAUDE Adverse Event Report: ARTHREX, INC. SPEED CINCH CURVED NEEDLE W/2PEEK IMP & 2-0 FW; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-4502
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
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 one of two submissions for the same patient event.The other is 1220246-2017-00209 ((b)(4)).The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review revealed nothing relevant to the event.If the device is returned and/or additional information is obtained, a follow-up report will be submitted.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.Per customer device will not be returned.
Event or Problem Description
It was reported that during a meniscal repair procedure, the ar-4502, speed cinch, lot: 10023651 ((b)(4)) did not function properly.The speed cinch successfully deployed and implanted the first implant however, the speed cinch misfired on the second implant.The first implant was removed and a second speed cinch of a different lot, lot: 10048688 ((b)(4)) was opened and again, the speed cinch successfully deployed and implanted the first implant however, the cinch misfired on the second implant.The first implant was removed however, the surgeon was unable to repair the patient's meniscus and he ended up converting to a menisectomy.The surgeon stated that he's bringing the patient back for an acl reconstruction and will reassess the meniscus intra-operatively.

• Brand Name: SPEED CINCH CURVED NEEDLE W/2PEEK IMP & 2-0 FW
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6631078
• Report Number: 1220246-2017-00210
• Device Sequence Number: 1083423
• Product Code: GAT
• UDI-Device Identifier: 00888867102675
• UDI-Public: 00888867102675
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132043
• 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
• Report Date (Section B): 06/09/2017

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: 05/01/2021
• Device Catalogue Number: AR-4502
• Device Lot Number: 10048688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/09/2017
• 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