MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 9.5MM; BIT, SURGICAL

Catalog Number 72204045

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an unknown procedure, the acufex trunav did not close after flipping inside and finally broke.The procedure was completed with a backup device with no significant delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H6: the reported 9.5mm retrograde drill, 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, 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 advancing the tip of the drill to a location that allows retraction of the cutting blade after use.Bone lodged within the drill housing.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 9.5MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9497152
• MDR Text Key: 173299050
• Report Number: 1219602-2019-01588
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Catalogue Number: 72204045
• Device Lot Number: 4726303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1