MAUDE Adverse Event Report: ZIMMER M/DN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

Zimmer m/dn nail, quantity 1.It was reported that during the removal of a m/dn stainless steel tibial nail on (b)(6), 2014 the drill bit and extraction bolt broke in the process of the attempted nail removal.The hardware removal was planned due to patient complaints of pain and to facilitate a total knee in the future.The surgeon first attempted to remove the nail with a synthes extraction bolt which the tip broke inside the nail.Then he attempted to use a synthes high speed drill bit and that broke.All pieces of the broken drill bit were retrieved.The surgeon then drilled a hole in the proximal end of the nail as to use an impactor to remove the nail but was unsuccessful; no damage was noted to the impactor.The surgeon then cut the proximal end of the nail in preparation for a future total knee replacement.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: M/DN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 17532417
• MDR Text Key: 321412624
• Report Number: MW5139325
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1