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 Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy, while the surgeon was engaging the sutures through the speedscrew knotless anchor, the sutures stopped moving as the surgeon was twisting the back of the anchor.As it became evident the sutures were not advancing the surgeon set the internal locking mechanism and detached the anchor from the inserter, and then use the removal owl to back the anchor out of the bone.The anchor pushed into the humeral head as the bone quality was relatively poor.The sutures were cut flush with the bone and inserted into a new speedscrew knotless anchor to complete the procedure, drilling an additional bone hole.The original anchor was left buried deep in the bone.5 minutes delay was reported, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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 that no clinical factors were found which would have contributed to the reported events.The speedscrew knotless anchor and sutures are implantable, biocompatibility is not an issue.Micro-motion or movement is unlikely as it was reported that the anchor was ¿left buried deep in the bone.¿ there is potential risk for tissue inflammation and/or pain.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.
Event or Problem Description
It was reported that during a shoulder arthroscopy, while the surgeon was engaging the sutures through the speedscrew knotless anchor, the sutures stopped moving as the surgeon was twisting the back of the anchor.As it became evident the sutures were not advancing the surgeon set the internal locking mechanism and detached the anchor from the inserter, and then use the removal owl to back the anchor out of the bone.The anchor pushed into the humeral head as the bone quality was relatively poor.The sutures were cut flush with the bone and inserted into a new speedscrew knotless anchor to complete the procedure, drilling an additional bone hole prepared with a speedscrew tap.The original anchor was left buried deep in the bone.5 minutes delay was reported, 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: 17585280
• Report Number: 3006524618-2023-00326
• Device Sequence Number: 3584344
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: 08/26/2025
• Device Catalogue Number: OM-6500
• Device Lot Number: 2099796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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: Other
• Patient Sex: Unknown