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

Model Number OM-6500

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 291621478
• Report Number: 3006524618-2022-00236
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male