MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 7.5MM; BIT, SURGICAL

Catalog Number 72204041

Device Problem Break (1069)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a knee arthroscopy, the blade broke the tip of the acufex retrograde drill.The procedure was completed with a smith and nephew back up device.There was a delay greater than 30 minutes and no further complications were reported.

Manufacturer Narrative

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 retrograde bit was returned with the actuator bar connected to the grey slider and the orange depth guide in place.The distal tip of the channel is clogged with biological debris and the retrograde bit has the edge fractured away on one side.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 no similar reported events.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force during use, failure to retract the guidewire far enough back before attempting to deploy the blade, using the reverse function while drilling, attempting to deploy the blade while still inside the bone tunnel, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 7.5MM
• 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: 18229677
• MDR Text Key: 329268978
• Report Number: 1219602-2023-02325
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037708
• UDI-Public: 00885554037708
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204041
• Device Lot Number: 4997187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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