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

Catalog Number	OM-6500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a procedure, the suture of two (2) opus speedscrew implants broke.The procedure was resumed, with an equivalent sn back-up.It is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference case- (b)(4).H2: additional information: b5 and h6: health effect - impact code.
Event or Problem Description
It was reported that, during a procedure, the suture of two (2) opus speedscrew implants broke there was a locking defect of one of the two wires in the anchors.The procedure was resumed, with an equivalent sn back-up.No additional hole was drilled.It is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H10 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.An image evaluation was performed and found the medical device inside a transparent plastic tray with a blue suture strand is also visible, coiled within the packaging.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.A review of the material specifications found that tensile strength requirements are specified, and a certificate of analysis is required with each shipment.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual evaluation showed two devices were returned together in a single bio bag (b)(4).The snares of each device have been run.One device has a mini-tape round-flat-round suture threaded through the anchor eyelet and cut off below the anchor proximal end.The other device has a blue ultratape threaded through the anchor eyelet and cut off below the anchor proximal end.Per the ifu, "use only magnumwire suture usp #2 (metric size 5 except for diameter).Use of other sutures will compromise suture locking integrity." the anchors, which are still on the insertion devices, have no visible defect.Bio debris is present.Based on the condition of the product material found during visual inspection, no fracture of the implant could be confirmed.Additional material testing is not required.An image evaluation was performed and found the medical device inside a transparent plastic tray with a blue suture strand is also visible, coiled within the packaging.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.A review of the material specifications found that tensile strength requirements are specified, and a certificate of analysis is required with each shipment.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.Based on this investigation, the need for corrective action is not indicated.

• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23677085
• Report Number: 3006524618-2025-00679
• Device Sequence Number: 13362438
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 817470005196
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: OM-6500
• Device Lot Number: 2179414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 12/24/2025; 03/02/2026
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/06/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2025
• 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