MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR TWINFIX ULTRA 4.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72202633
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/02/2023
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 ankle osteosynthesis procedure using a twinfix ultra 4.5mm awl-dilator, when impacting the primer and subsequently threading it as requested by the technician, upon removal, it was found that the tip broke inside the bone.The doctor chose not to try to remove it and the piece was left inside of the patient.The procedure was successfully completed without surgical delay using the same device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was identified; however, the root cause of the reported event could not be determined since the device was not received 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 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 provided x-ray photo dated (b)(6) 2023, confirms the presence of a foreign body in the patient¿s ankle bone.However, based on a review of the information provided, the definitive clinical root cause of the reported breakage could not be determined.These devices are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long term implantation data is not available.Since the tip is retained in the patient¿s bone micro-motion and/or migration is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body.According to the report, the surgeon completed the procedure with the same device without a delay.Therefore, no further clinical/medical assessment is warranted at this time.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.

• Brand Name: AWL-DILATOR TWINFIX ULTRA 4.5MM
• 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: 16605045
• Report Number: 1219602-2023-00413
• Device Sequence Number: 17679566
• Product Code: NBH
• UDI-Device Identifier: 03596010647634
• UDI-Public: 03596010647634
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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 Model Number: 72202633
• Device Catalogue Number: 72202633
• Device Lot Number: 50553718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 08/24/2023
• Date Device Manufactured: 09/08/2015
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male