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

Catalog Number 72204042

Device Problem Mechanical Jam (2983)

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

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during surgery, when using the acufex trunav retrograde drill and trying to pull the cutting blade back into the shaft, it did not move.So, surgeon had to drill all the way through the tibia and had to use a medium xtendobutton round instead of the surgeon's normal technique (all inside drilling).It is unknown if there was a delay in the procedure.Procedure was changed, but it was completed with the same device.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: the reported 8mm trunav retrograde drill, used on treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the cutting blade would not retract.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not retracting the guidewire prior to deployment of the cutting blade.Not having sufficient clearance to allow the cutting blade to deploy properly.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: RETROGRADE DRL 8MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9823487
• MDR Text Key: 183112847
• Report Number: 1219602-2020-00511
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2024
• Device Catalogue Number: 72204042
• Device Lot Number: 4821694
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1