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

Model Number	OM-6500
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a procedure, the pull-in thread of two speedscrew implants broke prematurely.The procedure was completed with non-significant surgical delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
B5 was updated.H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned instrument shows no manufacturing abnormalities.The device was non-deployed and sutures are bundle toward the tip.Anchor is still attached.Product was out of the original packaging.No packaging returned.The devices are intended for single use.Basic functional testing was conducted.Both anchors were able to deploy once the bundled sutures were removed.Sutures green/white provided with both devices have been cut.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: 1) over tensioning the suture.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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during a rm suture procedure, the pull-in thread of two speedscrew implants was torn/broken prematurely.The procedure was completed with non-significant surgical delay using a back-up device.No patient complications were reported.

• Brand Name: OPUS SPEEDSCREW IMPLANT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14396168
• Report Number: 3006524618-2022-00236
• Device Sequence Number: 20330887
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 10/23/2024
• Device Model Number: OM-6500
• Device Catalogue Number: OM-6500
• Device Lot Number: 2080145
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2021
• 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 Age: 53 YR
• Patient Sex: Male