MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL TAPERED 3.8MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72201915
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tendon transposition procedure, the tapered awl was disassembled in the surgeon's hand when it was tried to remove it from the patient.Force was used and it still did not come off the bone, requiring the use of pliers and a hammer to remove it.All the pieces were removed from the patient.It is unknown how the procedure was completed.No surgical delay nor further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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 no 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Per case details, the tapered awl was reportedly, disassembled in the surgeon¿s hand, during an attempt to remove it from the patient.Per case correspondence, after the surgeon unsuccessfully applied force to remove the device, ¿pliers and a hammer¿ was used to remove the device.¿it was confirmed that all pieces were removed from the patient.¿ it is unknown how the surgical procedure was completed; however, there was ¿no surgical delay.¿ smith and nephew has not received the requested patient specific documentation, the device, and/or adequate materials to fully evaluate the root cause of the complaint.Patient impact beyond that which was reported could not be determined.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.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.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.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The handle at the proximal end of the awl has fractured away and was not returned.The awl shows wear from use down the shaft.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 no 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device, an impact event inconsistent with normal use, misuse or rough handling.No containment or corrective actions are recommended at this time.

• Brand Name: AWL TAPERED 3.8MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14438545
• Report Number: 1219602-2022-00754
• Device Sequence Number: 17557453
• Product Code: NBH
• UDI-Device Identifier: 03596010610607
• UDI-Public: 03596010610607
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/08/2024

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 Model Number: 72201915
• Device Catalogue Number: 72201915
• Device Lot Number: 50378093
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 08/25/2022; 01/05/2024; 01/05/2024
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/14/2022; 08/26/2022; 01/08/2024; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2011
• 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: Other
• Patient Age: 31 YR
• Patient Sex: Male