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

Model Number	OM-6500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a biceps tenodesis, the bicepstendon was armed with an ultrabraid 2 suture.When the button for tightening the sutures turned, the setting device of the opus anchor could not be removed and the tendon was not attached.Subsequently, the tendon was freed again and the anchor was removed from the bone.This showed that the eyelet was broken.The anchor was complete removed by turning the inserter out of the bone.A void was from the original hole was left in the patient.The procedure was completed changing the surgical technique only a subacromial decompression, with no fixation of the biceps tendon.Non-significant delay was reported, and no further complications were reported.
Event or Problem Description
It was reported that, during a biceps tenodesis, the bicepstendon was armed with an ultrabraid 2 suture.When the button for tightening the sutures turned, the setting device of the opus anchor could not be removed and the tendon was not attached.Subsequently, the tendon was freed again and the anchor was removed from the bone.This showed that the eyelet was broken.The anchor was completely removed from the patient by turning the inserter out of the bone.A void from the original bone hole was left in the patient.The procedure was completed changing the surgical technique by performing only a subacromial decompression, with no fixation of the biceps tendon.Non-significant delay was reported, and no further complications were reported and the surgeon was satisfied with the result.Patients are doing well and no further problems are expected.
Additional Manufacturer Narrative
B5 and h6 (health effect - clinical code) fields were 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 and cracked.Product was out of the original packaging.No packaging returned.The device is intended for single use.Basic functional testing was conducted.The anchor was not able to deploy.Sutures green/white provided with the device has been cut.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.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.It was noted that the anchor was removed from the patient.Per e-mail communication the patient ¿are doing well and no further problems are expected.¿ should any additional clinical information be provided this complaint will be re-evaluated.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) excessive force.No containment or corrective actions are recommended at this time.G1 was corrected.
Additional Manufacturer Narrative
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 and cracked.Product was out of the original packaging.No packaging returned.The device is intended for single use.Basic functional testing was conducted.The anchor was not able to deploy.Sutures green/white provided with the device has been cut.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 review of the drawing found the tensile strength, and material specifications are verified for compliance.Based on the condition of the product material found during visual inspection, it was determined the device damage was caused by the application of improper/excessive force.Additional material testing is not required.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.It was noted that the anchor was removed from the patient.Per e-mail communication the patient ¿are doing well and no further problems are expected.¿ should any additional clinical information be provided this complaint will be re-evaluated.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) excessive force.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 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: 13935719
• Report Number: 3006524618-2022-00115
• Device Sequence Number: 4654400
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K081893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 10/09/2024
• Device Model Number: OM-6500
• Device Catalogue Number: OM-6500
• Device Lot Number: 2080143
• 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: 03/13/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 09/07/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 08/31/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 30 YR
• Patient Sex: Male