MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8MM; BIT, SURGICAL

Model Number 72204042

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during an unspecified surgery, the cutter blade of the "8mm acufex trunav retrograde drill" could not be deployed and opened in the joint because the wire that retracts the cutter blade broke.The broken wire was successfully removed from the patient.The procedure was successfully completed without significant delay using a back-up device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned in good condition with minimal debris.The laser markings were present on the shaft.A functional evaluation concluded that the cutter blade could not be rotated out through the movement of the grey slider, likely due to a broken internal wire.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: read these instructions completely prior to use.The cannulated power drill must always be set to forward when drilling tunnels and retrograde-drilling sockets.Prior to deploying the cutting blade, ensure that the guide wire is retracted within the groove approximately 1.5 inches (38 mm) within the retrograde drill shaft and is not in the drill head window.The groove in the guide wire provides tactile feedback that it is retracted to the proper position.This will prevent possible device failure.The device is intended to drill in a retrograde motion only when cutting blade is deployed.Antegrade drilling while the cutting blade is deployed may result in device failure.Use only the smith & nephew devices provided in the retrograde drill kit.As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force or bending on the device, inconsistent rotational speed, use of drill set to reverse, or use in excessively hard bone.

• Brand Name: RETROGRADE DRL 8MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10999182
• MDR Text Key: 221229348
• Report Number: 1219602-2020-02046
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037715
• UDI-Public: 00885554037715
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204042
• Device Catalogue Number: 72204042
• Device Lot Number: 4905283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention