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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLUSH SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC
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SMITH & NEPHEW, INC. FLUSH SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Model Number 72203053
Device Problems Break (1069); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a shoulder labral repair surgery, the flush cutter would not open and close properly and a small part at the front end became separated from the main shaft.The procedure was completed without significant delay using a back-up device.No patient injury or 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
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the instructions for use found: ¿-read these instructions completely prior to use.- 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.¿a review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
Manufacturer Narrative
H10: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found the distal tip had fractured off.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that during a shoulder labral repair surgery, the flush cutter would not open and close properly and a small part at the front end became separated from the main shaft.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.
 
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Brand Name
FLUSH SUTURE CUTTER
Type of Device
ACCESSORIES,ARTHROSCOPIC
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
MDR Report Key11362046
MDR Text Key233018978
Report Number1219602-2021-00383
Device Sequence Number1
Product Code NBH
UDI-Device Identifier03596010653666
UDI-Public03596010653666
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72203053
Device Catalogue Number72203053
Device Lot Number50772356
Was Device Available for Evaluation? No
Date Manufacturer Received07/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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