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

Catalog Number	OM-6500
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, two (2) speed screw implants could not be tensioned after both anchors were placed.Both implants were removed from the patient.The procedure was completed with a smith and nephew back up device using the original drilled bone hole.There was a delay greater than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual evaluation showed the two devices were not returned in an original packaging.The implant is still on both the insertion tools.The implants have no visible defect.Device one: a blue/white suture has been threaded through the eyelet.Both the black and green tension wires have been coiled onto the reels in the handle.Bio debris is present.There are no visible defects.Device two: suture fibers are on the suture snares even though there is no longer a suture on the device.Both the black and green tension wires have been coiled onto the reels in the handle.There are no visible defects.A functional evaluation could not be performed on either device as the tension wires have already been used and coiled onto the reels.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 could not be determined since the reported malfunction could not be duplicated during the investigation.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: 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: 18418922
• Report Number: 3006524618-2023-00527
• Device Sequence Number: 7846753
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 03/02/2026
• Device Catalogue Number: OM-6500
• Device Lot Number: 2115402
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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