MAUDE Adverse Event Report: ARTHREX INC. SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-4502
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2017
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.This is the fourth 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 an acl w/ meniscal repair procedure, the surgeon was using a speed cinch w/ 2 peek implants (lot: 10135406).The first implant was implanted successfully however, the surgeon is unsure if the second implant deployed or not.The surgeon stated that the deployment felt smooth but cannot confirm if the implant was implanted as he did not tie them together.The suture ended up on the surgeon's hand when he pulled on them.He switched to a device from a different manufacturer and the case was completed without further incident.Arthrex sales representative was present for the case.There are no plans for a second surgery to remove the unretrieved device fragments.No patient harm.

• Brand Name: SPEED C" CRVED NDL 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: 6756596
• Report Number: 1220246-2017-00303
• Device Sequence Number: 11115780
• Product Code: GAT
• UDI-Device Identifier: 00888867102675
• UDI-Public: 00888867102675
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 04/01/2022
• Device Catalogue Number: AR-4502
• Device Lot Number: 10135406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/01/2017
• 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