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

Catalog Number 72204043

Device Problem Flaked (1246)

Patient Problem No Information (3190)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

Foreign zip code: (b)(6).The sample is under evaluation by the manufacturing site.

Event Description

It was reported that, during an acl repair surgery, when drilling the femoral tunnel with the 8.5mm trunav retrograde drill, after deploying the cutting blade, this one could not be retracted because it was lodged in the open position; therefore, the surgeon had to flip it back with another guidewire to finally drilling on retrograde mode and thus retract the blade from the patient.The procedure was successfully completed without significant delay using the same faulty device.No patient injuries or other complications were reported.Preliminary results of investigation have concluded that the drill showed shedding on the guidewire 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.

Manufacturer Narrative

H3, h6: one 72204043 8.5mm retrograde drill use during treatment, was returned for evaluation.Visual assessment confirms the complaint.Te actuator was broken, preventing the drill to close.Device showed shedding on guidewire.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper use of device.Per instructions for use: ¿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¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.

• Brand Name: RETROGRADE DRL 8.5MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 10049992
• MDR Text Key: 190768252
• Report Number: 1219602-2020-00759
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2024
• Device Catalogue Number: 72204043
• Device Lot Number: 4685487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR