• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR DISP KIT; ACCESSORIES,ARTHROSCOPIC Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15054620
MDR Text Key296160644
Report Number3006524618-2022-00325
Device Sequence Number1
Product Code NBH
UDI-Device Identifier00885556662632
UDI-Public00885556662632
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Date04/15/2024
Device Model Number72290125
Device Catalogue Number72290125
Device Lot Number2071618
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 Received07/19/2022
Supplement Dates Manufacturer Received10/13/2022
10/31/2023
Supplement Dates FDA Received10/17/2022
11/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
-
-