MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX TUNNEL GAUGE; BIT, SURGICAL

Model Number 72203169

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2020

Event Type  malfunction  

Event Description

It was reported that during an all inside acl, it was found that the 2.4mm drill wire included in the trunav set was defective.The laser marking at the tip of the drill was missing.When positioned the drill approximately as it should have been with laser marking and when the acufex was moved in the gauge over the wire from the outside, the gauge showed a femoral tunnel length of 65mm, which was considered very unlikely and it was necessary to used alternative measurement methods.The procedure was completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 72203169 acufex tunnel gauge, not intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, ¿during an all inside acl, it was found that the 2.4mm drill wire included in the trunav set was defective.The laser marking at the tip of the drill was missing.When positioned the drill approximately as it should have been with laser marking and when the acufex was moved in the gauge over the wire from the outside, the gauge showed a femoral tunnel length of 65mm, which was considered very unlikely and it was necessary to used alternative measurement methods¿.Images were provided by customer.An exact root cause cannot be determined with confidence viewing the image.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.This failure mode will continue to be monitored by post market surveillance, no further investigation is required at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.No further investigation is warranted at this time.

• Brand Name: ACUFEX TUNNEL GAUGE
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10262180
• MDR Text Key: 198493734
• Report Number: 1219602-2020-01017
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554030518
• UDI-Public: 00885554030518
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: 72203169
• Device Catalogue Number: 72203169
• Device Lot Number: 4726295
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention