MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRABRAID #2 COBRAID 38 LENGTH SINGL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	7210915
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the ultrabraid suture broke inside the patient when attaching to the ultrabutton plaque at the meniscal root.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One packet of 7210915 used in treatment was not returned for evaluation.Due to product unavailability, evaluation was limited.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use that contains recommendations, precautionary statements and instructions for proper use of product.This includes damage from handling.Avoid crushing or crimping due to the application of surgical instruments such as forceps or needle holders.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.If relevant information becomes available to assist with evaluation the complaint may be revisited.Product met specifications upon release to distribution.

• Brand Name: ULTRABRAID #2 COBRAID 38 LENGTH SINGL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10491395
• Report Number: 1219602-2020-01355
• Device Sequence Number: 19555408
• Product Code: GAT
• UDI-Device Identifier: 03596010511935
• UDI-Public: 3596010511935
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K041216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 7210915
• Device Lot Number: 74E1900435
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 89