MAUDE Adverse Event Report: ARTHROCARE CORPORATION DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	25-1810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a mpfl reconstruction, when surgeon was drilling hard bone in the superior patella, the tip of the drill from the kit for shoulder q-fix snapped inside the bone.The tip was left in situ.After the reconstruction, a scope was performed but drill was not in the joint.An ii image showed the broken drill bit in the superior pole of the patella.Surgery was completed with the same device.There was a delay of less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10: b7: bone quality added.Internal complaint reference (b)(4).H11: h1: updated to serious injury.
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 no similar reported events.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 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 clinical review states the adverse event was likely procedure related and the device had no influence on the event.The broken drill tip from the shoulder q-fix was manufactured and intended as externally communicating devices and it has not been approved for long term internal tissue exposure and long-term implantation data is not available.The drill tip was retained in the superior pole of the patella; therefore, micro-motion and migration is unlikely.However, we cannot make any conclusions on the impact of the non-implantable foreign body.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.Corrected data: h6: health effect clinical and impact code.

• Brand Name: DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19950177
• Report Number: 3006524618-2024-00311
• Device Sequence Number: 15656103
• Product Code: LXH
• UDI-Device Identifier: 00885556724613
• UDI-Public: 885556724613
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 25-1810
• Device Lot Number: 2143537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 09/17/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/11/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2024
• 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
• Patient Sex: Unknown