MAUDE Adverse Event Report: SYNTHES (USA), LLC TFNA NAIL TITANIUM 11MM/130 DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04-037.160S

Device Problem Break (1069)

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

Event Date 07/21/2020

Event Type  malfunction  

Event Description

Nail broke in 2 locations where helical blade passes through it.Nail was placed in patient on (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: TFNA NAIL TITANIUM 11MM/130 DEG
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES (USA), LLC
• MDR Report Key: 10338050
• MDR Text Key: 201053559
• Report Number: MW5095765
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04-037.160S
• Device Lot Number: H693627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• 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