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

Model Number OM-6500

Device Problem Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a rotator cuff repair, the opus speed screw implant failed; once inserted, it only moved one suture limb.The device was removed from the patient.The procedure was successfully completed without a significant delay using a back up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.The anchor is still attached and loaded with suture.A functional evaluation revealed sutures were loaded previously, during testing the anchor was able to be deployed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 review of risk management files found that the reported failure was documented appropriately.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: OPUS SPEEDSCREW IMPLANT
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11420632
• MDR Text Key: 234898249
• Report Number: 3006524618-2021-00269
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (y/n): N
• PMA/PMN Number: K081893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: OM-6500
• Device Catalogue Number: OM-6500
• Device Lot Number: 2050370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR