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

Model Number	72290125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during right shoulder stabilization/labral repair surgery, internal to the patient, when the drill from the disposable kit was inserted into the drill guide, it got stuck, therefore it was unable to make contact with the bone.While attempting to the remove the drill from the drill guide, a plastic component from the drill broke.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during, a shoulder stabilization/labral repair surgery, when the drill from the disposable q-fix kit was inserted into the drill guide, it got stuck, it did not make contact with the bone.While attempting to the remove the drill from the drill guide, a plastic component from the drill broke, all pieces were removed.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found that mishandling the device can result in failure.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection of the returned device shows the device is used.The drill bit is fractured.The lower drill bit is stuck in the drill guide.The blue drill stop and the upper drill bit are separated.The dowel pin is still in the drill stop.A functional test is not possible due to the drill guide being stuck.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 review states the clinical root cause of the reported events cannot be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.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.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).

• Brand Name: QFIX 1.8 MINI SUTURE ANCHOR DISP KIT
• Common Device Name: 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: 11151834
• Report Number: 3006524618-2021-00058
• Device Sequence Number: 3740400
• Product Code: NBH
• UDI-Device Identifier: 00885556662632
• UDI-Public: 00885556662632
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: 72290125
• Device Catalogue Number: 72290125
• Device Lot Number: 2049139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/10/2021; 02/10/2021; 11/22/2023; 11/28/2023
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/13/2021; 02/16/2021; 11/23/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2020
• 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 Sex: Unknown