MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8.5MM; BIT, SURGICAL

Model Number 72204043

Device Problem Material Separation (1562)

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

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).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 without its complementary components.The cutter was rotated slightly, but it appeared that the internal wire was disengaged from the grey slider.There was debris within the drill tip and cutter. a functional evaluation concluded that the grey slider was no longer connected to the rotating cutter and was unable to change its orientation.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 failure to retract guide wire, excessive force during use, use of the reverse function when drilling, or improper drilling direction when the cutting blade is deployed.

Event Description

It was reported that during an arthroscopy, using the acufex trunav retrograde drill, 8.5mm the blade did not deploy in joint space.Same episode happened to a 8.5mm drill replacement.The procedure was completed with a delay of 30 minutes.Surgery had to be completed with a 9mm drill.No patient injury or other complications were reported.Results of investigation have concluded that this device had debris within the drill tip and cutter which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: RETROGRADE DRL 8.5MM
• Type of Device: BIT, SURGICAL
• 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: 11399576
• MDR Text Key: 234276683
• Report Number: 1219602-2021-00425
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037722
• UDI-Public: 00885554037722
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72204043
• Device Catalogue Number: 72204043
• Device Lot Number: 4937121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention