MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCISSOR DOUBLE HOOK; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209491

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2020

Event Type  malfunction  

Event Description

It was reported that during a shoulder scope, the scissor double hook was having issues cutting the biceps, it looked like the device was missing one hook.Nothing was missing inside the patient, confirmed by x-ray.The procedure was completed without delay using a meniscus biter.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 7209491 double hook scissor instrument returned for evaluation.This is a four year old reusable instrument.The scissor action was free.The instrument¿s beak was visibly flared.A portion of the jaw is missing.The condition is aligned with leverage and or twisting of the distal end and leverage applied.This is not per recommendations.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 no allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Risk management files contain the reported failure.Product met specifications upon release to distribution.

• Brand Name: SCISSOR DOUBLE HOOK
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10229694
• MDR Text Key: 197604433
• Report Number: 1219602-2020-00978
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 7209491
• Device Lot Number: 50619163
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1