MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX TRUNAV RETROGRADE DRILL; BIT, SURGICAL

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

While in use, acufex trunav retrograde drill bit broke into 2 pieces.Two additional bits were attempted but failed to deploy reaming blade as intended.Fda safety report id# (b)(4).

• Brand Name: ACUFEX TRUNAV RETROGRADE DRILL
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 11529688
• MDR Text Key: 241509298
• Report Number: MW5100129
• Device Sequence Number: 3
• Product Code: GFG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/17/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 91