MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLUSH SUTURE CUTTER XL; ACCESSORIES,ARTHROSCOPIC

Model Number	72203052
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during shoulder arthroscopy procedure the product broke outside the patient but it did not lose any piece.No delay and a back up was available to complete the procedure.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 72203052 flush suture cutter xl used for treatment, was not returned for evaluation.Due to product unavailability evaluation was limited.If further information becomes available the complaint may be revisited.This is a six year old reusable instrument.Periodic maintenance is required.Allegation description aligns with repeat use, wear and force.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 similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: FLUSH SUTURE CUTTER XL
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10393939
• Report Number: 1219602-2020-01232
• Device Sequence Number: 3446577
• Product Code: NBH
• UDI-Device Identifier: 03596010654182
• UDI-Public: 03596010654182
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72203052
• Device Catalogue Number: 72203052
• Device Lot Number: 50527037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1