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

Model Number	72202588
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, the tip of the xl suture cutter fell into the patient's body, the pieces remained in the patient and were not removed.The procedure was completed with a s+n back up device.There was a non-significant delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the tip of the xl suture cutter fell into the patient's body, the device was removed by the surgeon.The procedure was completed with a s+n back up device.There was a non-significant delay and no further complications were reported.
Additional Manufacturer Narrative
H10: 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 device shows wear from use and the product identification markings are significantly degraded.The carbide insert in the distal tip is fractured and there is material missing.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 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.A clinical review states two intraoperative photos were reviewed and confirm the reported breakage.Of the two images, one arthroscopic photo appears to show the broken tip of the device inside the patient and the second photo appears to show the suture cutter with a missing tip.The patient impact beyond the reported events is not anticipated as the broken device pieces were reportedly removed from the patient and no patient harm has been alleged.The root cause was associated with component failure.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: XL SUTURE CUTTER
• 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: 14421522
• Report Number: 1219602-2022-00740
• Device Sequence Number: 5527694
• Product Code: NBH
• UDI-Device Identifier: 03596010652430
• UDI-Public: 03596010652430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202588
• Device Catalogue Number: 72202588
• Device Lot Number: 35077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 12/19/2023
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/30/2022; 12/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown