MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDSTITCH NEEDLE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	OM-8850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during the surgery the speedstitch needle tip broke off inside the patient's anatomy, the broken pieces were found with a scope and then removed.Delay greater than 30 minutes was reported.Smith and nephew back-up device was available to complete the surgery.No other complications reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H2: additional information in d4 (lot no and exp date) and h4 (mfg.Date).
Additional Manufacturer Narrative
H10: additional information in d4 (lot no).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection showed the device was returned with original packaging showing lot 2062206.The needle is in an unloading tool.The capture end of the needle is broken off and was not returned.Bio debris is present.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 the ifu warns that excessive force should not be placed on this instrument.Excessive force can result in failure.It also notes, do not twist, bend, or apply torsional forces to the needle loader.Only apply axial forces.The patient impact beyond the reported is not anticipated as the broken piece was reportedly retrieved from the patient.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include hitting the device tip against a hard surface, using the device as a lever to enlarge surgical site or mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.

• Brand Name: SPEEDSTITCH NEEDLE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11905797
• Report Number: 3006524618-2021-00677
• Device Sequence Number: 11109634
• Product Code: GAT
• UDI-Device Identifier: 00817470005929
• UDI-Public: 00817470005929
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/20/2023

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 Expiration Date: 10/08/2023
• Device Catalogue Number: OM-8850
• Device Lot Number: 2062206
• 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: 05/11/2021
• Supplement Date Received by Manufacturer: 09/21/2023; 09/22/2023; 12/14/2023
• Initial Report FDA Received Date: 05/30/2021
• Supplement Report FDA Received Date: 09/22/2023; 09/25/2023; 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown