MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71631451

Device Problem Crack (1135)

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

Event Date 01/17/2018

Event Type  Injury  

Event Description

It was reported a delay in surgery above 30 minutes since dr.Had to use vice grips to target correctly the screws through the nail.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A visual inspection of the returned meta-tan drill guide confirms the stated failure.The device is fractured at handle/femoral wings connection.From the analysis conducted during this investigation, it was concluded that the drill guide handle portion fractured mostly likely due to overload.An overload fracture can occur if the mechanical loads applied to the drill guide exceeded the strength of the material.It is likely the fracture initiated due to repeated impact strikes during repeated nail insertion use.It was unknown if the fracture in the drill guide handle was initiated in a prior surgery.The device exhibits signs of repeated use and significant wear.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.The clinical/medical team concluded, it was reported that there was a crack in the metatan targeter, resulting in a procedural delay.No patient injury was sustained as a result of this device related incident aside from the extended surgery time, and the procedure was completed successfully.No further medical assessment is warranted based on the information provided.If new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: META-TAN DRILL GUIDE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7265854
• MDR Text Key: 99879234
• Report Number: 1020279-2018-00164
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71631451
• Device Lot Number: 15KSP0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1