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

Model Number 72202633

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event 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.

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
• Type of Device: 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
• MDR Text Key: 311917534
• Report Number: 1219602-2023-00413
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010647634
• UDI-Public: 03596010647634
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 08/24/2023
• Date Device Manufactured: 09/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male