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	11/20/2018
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 not returned for evaluation.The device was reported to have been discarded.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 meniscus repair procedure, the suture on both speed cinches, lot: 10145050 and 10175535, broke before tying the knots.Both speed cinches were used correctly as per dfu.Additional information has been requested.Additional information provided (b)(6) 2018: three of the four implants were left in the meniscus.The fourth implant did not deploy properly and was easily retrieved.The case was completed with a meniscal cinch 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: 8160206
• Report Number: 1220246-2018-00797
• Device Sequence Number: 2203535
• Product Code: GAT
• UDI-Device Identifier: 00888867102675
• UDI-Public: 00888867102675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/13/2018

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: 05/31/2022
• Device Model Number: SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW
• Device Catalogue Number: AR-4502
• Device Lot Number: 10145050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/13/2018
• 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