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	09/29/2017
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.Device history record review revealed nothing relevant to this event.The device was requested and is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.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 during a meniscal repair for a large bucket handle tear, the first ar-4502 went in successfully.As the surgeon worked around the rim of the tear, there were four unsuccessful attempts.The 2nd and 3rd device, the first implant deployed but the second would not.The first implants were removed.With the 4th device, the suture tore during cinching.The second implant was removed; the first implant remains in the patient.With the fifth device, the second implant would not deploy.The case was completed with an outside/in technique with #2 fiberwire.There were no reps present in the case.Additional information received: the first implant of the fifth device was completely removed.Patient was a (b)(6) year old female.
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.This is a follow-up submission due to device evaluation.Device history record review revealed nothing relevant to this event.A total of five devices were returned for evaluation.Implants and suture constructs associated with the devices were not returned for evaluation, therefore, the reported event of the suture breaking during cinching could not be verified.All of the returned devices' shafts were bent.The four devices actuated as intended.However, the sutures and the implants were not returned; therefore, the cause of the complainant's event could not be determined.The fifth device's second needle did not actuate completely.Measurement was taken on the #2 needle, and it was within specification.The most likely cause of this type of event is excessive movement of the needle from tear, bent tip and/or the user not following the deployment sequence as stated in the surgical technique guides such as squeezing and releasing trigger out of sequence, and premature squeezing and releasing of the trigger.Bent tip event is typically caused by leveraging/ prying the device during implantation procedure.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 during a meniscal repair for a large bucket handle tear, the first ar-4502 went in successfully.As the surgeon worked around the rim of the tear, there were four unsuccessful attempts.The 2nd and 3rd device, the first implant deployed but the second would not.The first implants were removed.With the 4th device, the suture tore during cinching.The second implant was removed; the first implant remains in the patient.With the fifth device, the second implant would not deploy.The case was completed with an outside /in technique with #2 fiberwire.There were no reps present in the case.Additional information received: the first implant of the fifth device was completely removed.Patient was a (b)(6) year old female.

• 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: 6958014
• Report Number: 1220246-2017-00383
• Device Sequence Number: 10961221
• Product Code: GAT
• UDI-Device Identifier: 00888867102675
• UDI-Public: 00888867102675
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 12/13/2017

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: 10141384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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: 16 YR