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

Catalog Number	OM-6500
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a rotator cuff repair, the speedscrew implant's snare got stuck in the anchor, when tensioning the sutures, and pulled off the internal suture, therefore it was not able to gain adequate tension on the sutures in the cuff.The anchor was removed with difficulty, and it broke before it was completely removed.A bone nibbler was used to remove the broken part of the anchor.The procedure was successfully completed with a surgical delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10 h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an evaluation of the customer provided image was performed and found the shaft of the device with part of the broken anchor still on.The broken part of the anchor is lying next to it.The sutures are not shown and there's blood on the device.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 failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor material specifications found that tensile strength requirements are specified, and a certificate of analysis is required with each shipment.The root cause of the reported events could not be determined since findings cannot lead to a clear cause of the reported events.Factors that could have contributed to the reported events include an application of excessive force or improper tensioning.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: 18619968
• Report Number: 3006524618-2024-00040
• Device Sequence Number: 11364280
• 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): 02/12/2024

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: 08/31/2026
• Device Catalogue Number: OM-6500
• Device Lot Number: 2130377
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/12/2024
• Date Device Manufactured: 08/31/2023
• 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