MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE 1.3MM WH/BL W/ 36.6 RV CT NDL; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SUTURETAPE 1.3MM WH/BL W/ 36.6 RV CT NDL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported during a achilles tendon repair procedure as the surgeon was passing the ar-7502 suturetape through the tendon, the needle pulled off the suture.Opened a second device from the same lot and the same issue occurred.The rep reported all broken fragments were fully retrieved from the patient.The case was completed by using another manufacturer's suture.

• Brand Name: SUTURETAPE 1.3MM WH/BL W/ 36.6 RV CT NDL
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11990341
• Report Number: 1220246-2021-03249
• Device Sequence Number: 14494820
• Product Code: GAT
• UDI-Device Identifier: 10888867288833
• UDI-Public: 10888867288833
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUTURETAPE 1.3MM WH/BL W/ 36.6 RV CT NDL
• Device Catalogue Number: AR-7502
• Device Lot Number: 100012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1