MAUDE Adverse Event Report: ARTHROCARE CORPORATION DISPOSABLE KIT 2.8MM SHOULDER Q-FIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	25-2810
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, the shoulder q-fix kit, when opened from the sealed box, had heat damage to the packaging causing the plastic to shrink away from the seal.It was not used as it was not sterile.The procedure was successfully completed with non-significant surgical delay using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found three images showing different angles of the packaging and the device.The first one is a upper view, showing the label with the part number 25-2810 and lot 2106117., with the packaging wrinkled.The second image is a right view of the packaging showing the packaging shrink away, with sings of rough handling and exposure to heat.The third image is a left view, showing completely all parts shrink away of the packing.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 root cause could not be determined since findings cannot lead to a clear cause of the reported event.Please refer to the instructions for use for precautions and warnings related to the use of the device.The complaint was escalated to the manufacturing team and after review has determined no containment or corrective actions are recommended at this time as at the packaging area there are no heat related operations as the devices are only put into the white boxes, and all 100% sealed trays are inspected.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).H3, h6: part of the reported device was received for evaluation.A visual evaluation showed no original packaging was returned for inspection.The drill, drill guide, and the obturator were returned.The drill guide has bio debris on it.An image evaluation was performed and found three images showing different angles of the packaging and the device.The first one is a upper view, showing the label with the part number 25-2810 and lot 2106117., with the packaging wrinkled.The second image is a right view of the packaging showing the packaging shrink away, with sings of rough handling and exposure to heat.The third image is a left view, showing completely all parts shrink away of the packing.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 root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include damage during shipping, mishandling or excessive exposure to high environmental temperatures.The complaint was escalated to the manufacturing team and after review has determined no containment or corrective actions are recommended at this time.

• Brand Name: DISPOSABLE KIT 2.8MM 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: 18149983
• Report Number: 3006524618-2023-00443
• Device Sequence Number: 6747352
• Product Code: LXH
• UDI-Device Identifier: 00885556724651
• UDI-Public: 885556724651
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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 Expiration Date: 12/05/2025
• Device Catalogue Number: 25-2810
• Device Lot Number: 2106117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 05/02/2024; 09/27/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 05/06/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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