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)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the suture cutter snapped in half.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The shaft is disengaged from the handle and the entire device shows significant wear.The product identification is legible but the lot number is worn away.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors, that could have contributed to the reported event, include an application of unintended inappropriate or excessive force to the device, or wear from day to day use.No containment or corrective actions are recommended at this time.

• Brand Name: FLUSH SUTURE CUTTER XL
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15762739
• Report Number: 1219602-2022-01701
• Device Sequence Number: 6353227
• Product Code: NBH
• UDI-Device Identifier: 03596010654182
• UDI-Public: 03596010654182
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown