MAUDE Adverse Event Report: ARTHREX, INC. PARS SUTURE IMPLANT KIT W/ SUTURETAPE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	PARS SUTURE IMPLANT KIT W/ SUTURETAPE
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
An arthrex employee has reported that the tapes did not hold intra operative after minimal load.All knots opened very easily after five strokes.The surgeon needed to change the surgical technique from pars to krakow seam.The surgery could not be completed in a minimally invasive manner, a larger incision had to be made and an open suture technique used to finish the surgery successfully.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified breakage at one end of the c7299-67 white suturetape component.Receiving inspection paperwork for all sub-components of the suturetape were reviewed, and it was noted that no abnormalities were present in terms of the load testing performed on samples selected from the same batches as either of the components returned for investigation.As such, the root cause is undetermined, but a most likely probable cause can be linked to interference between the suture constructs and the sharp edge of the bone tunnel, and/or through the application of excessive force during tightening.

• Brand Name: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10379004
• Report Number: 1220246-2020-02007
• Device Sequence Number: 14239336
• Product Code: GAT
• UDI-Device Identifier: 00888867288263
• UDI-Public: 00888867288263
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 02/28/2025
• Device Model Number: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Device Catalogue Number: AR-8862DS
• Device Lot Number: 10695144
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other