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

Model Number	SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a meniscal repair procedure, the surgeon was using a speed cinch, ar-4502, lot: 10175535.The surgeon implanted the first implant with no incident.When he went to insert the second implant, the second implant would not deploy.The surgeon removed the first implant with a pair of graspers and opened up a second speed cinch, ar-4502, lot: 10184671.The first implant deployed and seated with no issue but again, the second implant did not deploy.The surgeon removed the first implant with graspers and switched to a menisectomy instead.

• 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: 7922599
• Report Number: 1220246-2018-00674
• Device Sequence Number: 16720677
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: 10/31/2022
• Device Model Number: SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW
• Device Catalogue Number: AR-4502
• Device Lot Number: 10175535
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/01/2018
• 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
• Patient Weight: 98