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 Information (3190)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, 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 1220246-2017-00143 ((b)(4)).The device was requested for evaluation but was discarded 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 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 meniscal repair procedure, the surgeon was attempting to use a speed cinch w/ 2 peek implants.The first speed cinch (lot: 10048688, line (b)(4)) snapped at the tip upon insertion into the meniscus for the first time.The speed cinch tip was hanging on by a thread when the device was retracted from the knee.A second speed cinch of the same lot (lot: 10048688, line (b)(4)) was opened and used and again, upon insertion into the meniscus to insert and seat the first implant, the tip snapped and was barely hanging on.The speed cinch was discarded and a third speed cinch of the same lot (lot: 10048688, line (b)(4)) was opened and again, broke on insertion leaving the tip hanging.The speed cinch was discarded and a fourth speed cinch, this time of a different lot (10048684, line (b)(4)), was opened and the surgeon was able to successfully seat the first implant however, when the surgeon went to fire the second implant, the implant did not deploy correctly and pulled right out of the meniscus.The surgeon cut the suture and tied the implant, leaving it in the meniscus.A fifth speed cinch of the same lot (10048684, line (b)(4)) was opened and used and again, the first implant was seated without incident but, as the surgeon fired the second implant, the implant, again deployed incorrectly and pulled right out.Again, the surgeon cut the suture and left the first implant seated in the meniscus.A sixth speed cinch of a different lot (lot: 10056166, line (b)(4)) was opened and the first implant deployed and seated fine however, when the surgeon went to fire the second implant, the trigger jammed and the second implant would not deploy.The surgeon cut the suture, tied a knot and left the first implant in the meniscus.A seventh speed cinch of a different lot (lot: 10055482, line (b)(4)) was opened and the trigger on this speed cinch was jammed and no implants ever deployed.The surgeon toggled between both implants and tried again to deploy but the trigger was jammed and would not pull.After seven speed cinches were used, the surgeon switched to a another manufacturer's device and the case was completed.All seven devices were discarded.A total of three implants were left in the meniscus of the patient.

• 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: 6520043
• Report Number: 1220246-2017-00144
• Device Sequence Number: 788944
• Product Code: GAT
• UDI-Device Identifier: 00888867102675
• UDI-Public: 00888867102675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/21/2017

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: 07/01/2021
• Device Catalogue Number: AR-4502
• Device Lot Number: 10056166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-4502 SPEED CINCH LOT 10048684; AR-4502 SPEED CINCH LOT 10055482
• Outcome Attributed to Adverse Event: Other