MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE KIT HIP FOR 1.8MM Q-FIX IMP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	25-1811
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the drill broke.All broken pieces were removed from the patient.The procedure was successfully completed with three minutes of delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual evaluation showed the device was not received in any original packaging.The drill shaft/tip are in the drill guide.The drill shaft broke off approximately 1 inch below the drill stop.There are grooves at the break point.A functional evaluation showed the drill shaft could not be removed from the drill guide.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include: 1) incorrect bone hole preparation.2) improper depth insertion.3) excessive force.No containment or corrective actions are recommended at this time.

• Brand Name: DISPOSABLE KIT HIP FOR 1.8MM Q-FIX IMP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12515894
• Report Number: 3006524618-2021-00933
• Device Sequence Number: 12054318
• Product Code: LXH
• UDI-Device Identifier: 00885556724620
• UDI-Public: 885556724620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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
• Report Date (Section B): 11/03/2023

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: 10/31/2023
• Device Catalogue Number: 25-1811
• Device Lot Number: 2060776
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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
• Patient Sex: Unknown