MAUDE Adverse Event Report: ARTHROCARE CORPORATION SMARTSTITCH PP CONNECTOR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	OM-8010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the top jaw of the smartstitch broke off when activated.The device broke inside the patient and the broken piece came out and fell on the floor when the surgeon was removing the device.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual evaluation showed the device was returned with original packaging with the batch number of the complaint on the label.The top jaw has become unhooked from the internal s-clamp hook, which allowed it to fall from the device.Bio debris is present.A functional evaluation using a reference smartstitch handle showed that the connector will load to the handle, the s-clamp hook moves forward and back, and the suture needles worked independently and simultaneously.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 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 component failure.Factors that could have contributed to the failure include rough handling or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SMARTSTITCH PP CONNECTOR
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19856769
• Report Number: 3006524618-2024-00289
• Device Sequence Number: 8111492
• Product Code: GAT
• UDI-Device Identifier: 00817470006971
• UDI-Public: 00817470006971
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Expiration Date: 04/04/2026
• Device Catalogue Number: OM-8010
• Device Lot Number: 2116441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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