MAUDE Adverse Event Report: ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR DISP KIT; ACCESSORIES,ARTHROSCOPIC

Model Number 72290125

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 06/23/2022

Event Type  Injury  

Event Description

It was reported that, during an arthroscopy, the tip of the qfix mini drill bit broke off, the surgeon reckons it had lodged inside the humeral shaft and cannot be retrieved.The procedure was completed with a s+n back up device in the same bone hole.It is unknown if there was a delay and no further complications were reported.The current status of the patient is fine.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states this case reports the breakage of the qfix mini drill bit and per report the broken drill bit not able to be retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.Based on the limited information provided the root cause for the reported breakage could not be determined.The drill is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and retained foreign body could not be definitively determined.Micro-motion and/or movement is unlikely as it was reported that the drill bit was left in the humeral shaft.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event is excessive force.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

H10: internal complaint reference (b)(4).The reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The tip of the drill is broken off.The flutes are full of bio debris.There is scarring along the full length of the shaft.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical states the drill is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and retained foreign body could not be definitively determined.Micro-motion and/or movement is unlikely as it was reported that the drill bit was left in the humeral shaft.There is potential risk for tissue inflammation and/or pain.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force (2) improper alignment of the handle.No containment or corrective actions are recommended at this time.H11: corrected information in h6 (health effect - impact code).

• Brand Name: QFIX 1.8 MINI SUTURE ANCHOR DISP KIT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 15054620
• MDR Text Key: 296160644
• Report Number: 3006524618-2022-00325
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556662632
• UDI-Public: 00885556662632
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: 72290125
• Device Catalogue Number: 72290125
• Device Lot Number: 2071618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 10/31/2023
• Supplement Dates FDA Received: 10/17/2022; 11/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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 Outcome(s): Other; Required Intervention