MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLUSH SUTURE CUTTER; DEVICE, GENERAL MEDICAL

Model Number	72203053
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the flush suture cutter broke.The procedure was successfully completed without 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 72203053 x long flush suture cutter used in treatment was not returned for evaluation.The item is a six year old reusable instrument.The allegation aligns with repeat use and wear, unknown recommended maintenances and potential forces applied.Due to product unavailability, evaluation was limited.If further information becomes available, the complaint may be revisited.Per instructions for use: ¿these instruments are designed for repeated use with proper care and handling.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ 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.Product met specifications upon release to distribution.

• Brand Name: FLUSH SUTURE CUTTER
• Common Device Name: DEVICE, GENERAL MEDICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10410800
• Report Number: 1219602-2020-01255
• Device Sequence Number: 2403824
• Product Code: LDQ
• UDI-Device Identifier: 03596010653666
• UDI-Public: 03596010653666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/16/2020

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 Model Number: 72203053
• Device Catalogue Number: 72203053
• Device Lot Number: 50527037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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: Required Intervention