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

Model 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	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bicep tendon surgery when the opus speedscrew implant was inserted into the prepared hole, the first both ends of the suture were transported correctly by turning the handle, but suddenly one of the two ends of the suture stopped.It was not possible to give tension onto the second end of the suture.The other end could be tensioned by turning the handle.The anchor was completely removed using an extraction device (om-9630).The procedure was completed by changing the surgical technique into a tenotomy with a non-significant surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection showed the anchor was not returned.The plug is still in place on the inserter which is still inside the tube barrel sleeve.The white and green snaring lines were not returned.The device shows no other deficiencies.A functional evaluation of the device snare lines could not be performed due to the parts have already been deployed.The activation knob did move the plug as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was 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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that could have contributed to the failure include excessive force or torsion during use, use of the needle as a lever, misplaced force on the device actuator.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: 16994140
• Report Number: 3006524618-2023-00209
• Device Sequence Number: 3479907
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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
• Device Expiration Date: 08/22/2025
• Device Model Number: OM-6500
• Device Catalogue Number: OM-6500
• Device Lot Number: 2099803
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown