MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
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 that when the ar-7500 tape was loaded into the knee scorpion and inserted it into the meniscus, the tape broke.No adverse effect on the patient.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation confirms the suture broke approx.9.5 in.Total length of both returned suture was approx.19 inches.The needle was not returned.The cause is undetermined, however a likely cause is user-applied excessive forces.

• Brand Name: SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12032323
• Report Number: 1220246-2021-03289
• Device Sequence Number: 3800381
• Product Code: GAT
• UDI-Device Identifier: 00888867229228
• UDI-Public: 00888867229228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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 Expiration Date: 08/31/2025
• Device Model Number: SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
• Device Catalogue Number: AR-7500
• Device Lot Number: 100285
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1