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

Model Number	72203052
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the flush suture cutter x was broken.It is unknown whether the event happened during surgery and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.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.
Additional Manufacturer Narrative
H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned with a tip protector in place.There were signs of wear, but no debris.The shaft had dislodged from the handle, leaving the cutter inoperable.A functional evaluation revealed that the cutters did not operate unless the shaft was pushed into the handle fully.It did not remain in place, indicating that there may have been a component missing or broken within the handle.A review of the device 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.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include excess force during use, sterilization processes, or wear from day to day use.
Additional Manufacturer Narrative
H10: h2, h3, h6.The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned with a tip protector in place.There were signs of wear, but no debris.The shaft had dislodged from the handle, leaving the cutter inoperable.A functional evaluation revealed that the cutters did not operate unless the shaft was pushed into the handle fully.It did not remain in place, indicating that there may have been a component missing or broken within the handle.A review of the device 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.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include excess force during use, sterilization processes, or wear from day to day use.

• 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: 11183204
• Report Number: 1219602-2021-00142
• Device Sequence Number: 19781998
• Product Code: NBH
• UDI-Device Identifier: 03596010654182
• UDI-Public: 03596010654182
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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 Model Number: 72203052
• Device Catalogue Number: 72203052
• Device Lot Number: 50777772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/10/2021; 02/10/2021
• Initial Report FDA Received Date: 01/17/2021
• Supplement Report FDA Received Date: 02/11/2021; 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1