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	07/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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.The device was requested for evaluation but was not returned, 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.Complaint event most likely due to not following the surgical technique.Per the surgical technique implant #2 need to be advanced to the needle tip prior to advancing the needle through the meniscus.If this is not followed, implant could be potentially entangled with the suture and pulled back from the meniscus.The implant may be pulled out from meniscus due to the incorrect use of the depth stop or over tensioning of suture construct.Also the cause of the device tip breaking is due to leveraging the device as stated in the event description.This is the first 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 the first implant deployed; with the second implant, it came back out of the meniscus when securing with the knot pusher.The first implant remains in the patient.The second speed cinch was successful.With the third and fourth speed cinches, the first implant was successful; with the second implant, the tip of the device broke when the surgeon leveraged it up against the condyle; the second implant did not implant.Those first implants also remain in the patient.Patient female, 20s.Follow-up investigation: the 3rd speed cinch lost both implants and were not able to be recovered from patient.After the 4th speed cinch failed the case was completed using another manufacture's device.

• 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: 6739488
• Report Number: 1220246-2017-00293
• Device Sequence Number: 771948
• Product Code: GAT
• UDI-Device Identifier: 00888867102675
• UDI-Public: 00888867102675
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/25/2017

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: 05/01/2022
• Device Catalogue Number: AR-4502
• Device Lot Number: 10145050
• 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: 07/21/2017
• Initial Report FDA Received Date: 07/25/2017
• 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
• Patient Age: 20 YR