MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 10MM; BIT, SURGICAL

Catalog Number 72204046

Device Problem Material Separation (1562)

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The sample is under evaluation by the manufacturing site.

Event Description

It was reported that during an acl procedure, after the retrograde reaming of the tibial tunnel, the product failed to retract the protruding blade.The blade was forced to retract using other surgical instruments (probe and artery).The procedure was completed with a delay of 10-15 minutes using the same device.No patient injury or other complications were reported.Preliminary results of the investigation have concluded that the actuator wire of the drill is broken and it 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: the reported 10mm retrograde drill, used in treatment, has been returned for evaluation.Visual assessment of the drill showed the actuator wire is broken.As reported ancillary devices were used to close the cutting blade after the surgeon was unable to use the gray finger grip actuator, this likely led to the observed breakage of the actuator wire.There is bone lodged in the cutting blade.The cutter blade deploys and retracts manually from the drill housing.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not advancing the tip of the drill to a location that allows retraction of the cutting blade after use.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.

• Brand Name: RETROGRADE DRL 10MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9728964
• MDR Text Key: 181488649
• Report Number: 1219602-2020-00237
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2024
• Device Catalogue Number: 72204046
• Device Lot Number: 4888953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1