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

Catalog Number	7210914
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery when the knotting was being made the suture got broken, broken suture was removed from the patient's anatomy.The suture was replaced with another in order to complete the procedure.No patient injuries or significant delay was reported.
Additional Manufacturer Narrative
The reported ultrabraid suture intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the suture broke while tightening the knot.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: breakage of the suture anchor can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Use of excessive force.Managing the suture with a sharp instrument.Crushing or crimping the suture.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ULTRABRAID 2 WHITE 38 LENGTH SINGLE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8788778
• Report Number: 1219602-2019-00812
• Device Sequence Number: 13937362
• Product Code: GAT
• UDI-Device Identifier: 03596010511942
• UDI-Public: 03596010511942
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K041216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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 Catalogue Number: 7210914
• Device Lot Number: 74G1800386
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 73