MAUDE Adverse Event Report: ARTHROCARE CORPORATION OPUS SPEEDSCREW IMPLANT; SCREW, FIXATION, BONE

Catalog Number	OM-6500
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The implant is on the insertion tool.The implant has a hole from stress in it, this failure has been determined to be related to the reported event.There is bio debris on the suture and in the eyelet.A blue/white suture has been caught in one of the suture snare loops, pulled out of the eyelet prior to completing the loading through the eyelet, and bent toward the outer edge of the implant.The suture has been cut off just below the implant.The second snare loop has been deployed without a suture in it and is sitting at the top of the eyelet.A functional evaluation could not be performed since the suture loaders have deployed and are deformed.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.A review of the material specifications found that tensile strength is specified, and a certificate of analysis is required with each shipment.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force applied to the device or improper tensioning.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during a procedure, the sutures of the opus speedscrew did not went down when they were pulled.The sutures were cut and anchor was removed with the screwdriver.The procedure was completed using a smith and nephew back up device.There was a delay less than 30 minutes and no further complications were reported.

• Brand Name: OPUS SPEEDSCREW IMPLANT
• Common Device Name: SCREW, FIXATION, BONE
• 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: 18720688
• Report Number: 3006524618-2024-00071
• Device Sequence Number: 17719835
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K081893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2026
• Device Catalogue Number: OM-6500
• Device Lot Number: 2114149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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