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	10/24/2018
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that upon deploying the first anchor, the deployment rod on the ar-4502, speed cinch curved needle with two peek implants and 2.0 fiberwire was bent and unable to retract to allow the second anchor to deploy.Then after moving the number two position the trigger was firmly locked and would not allow passage of the second anchor.This occurred during a meniscal repair procedure.The rep stated that the surgeon elected to use the meniscal cinches to complete the repair.Additional information has been requested.Additional information received on 11/08/2018: the rep confirmed that a total of three ar-4502 failed during the meniscal repair procedure (lot: 10056961 / qty.1 and lot: 10135406 / qty.2).The rep stated that ar-4502 (lot: 10056961) and ar-4502 (lot: 10135406 x 1) failed while deploying the first anchor due to a bent deployment rod, and would not retract to allow the second anchor to deploy.The rep confirmed that the first anchor from both ar-4502 (lot: 10056961 & lot: 10135406 x1) deployed successfully, and were not retrieved.The third ar-4502 (lot: 10135406) had a trigger that was firmly locked and would not allow passage of the second anchor.The rep confirmed that the first anchor deployed properly, and was fully removed by pulling out on the suture.The case was completed by using an ar-4500 (lot unknown).The sales rep reported that there was no adverse event involved.

• 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: 8107651
• Report Number: 1220246-2018-00766
• Device Sequence Number: 2027172
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 04/30/2022
• Device Model Number: SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW
• Device Catalogue Number: AR-4502
• Device Lot Number: 10135406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/27/2018
• 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