MAUDE Adverse Event Report: TORNIER INC. PROTHESIS, TOE, HEMI- PHALANGEAL UNIVERSAL HANDLE

Catalog Number MHTLGTH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

It was reported the universal handle would not grip proximal/distal broach to pull out of the bone, causing considerable destruction of the bone as it was forced out, and harm to the patient.

• Brand Name: PROTHESIS, TOE, HEMI- PHALANGEAL UNIVERSAL HANDLE
• Type of Device: UNIVERSAL HANDLE
• Manufacturer (Section D): TORNIER INC.; 10801 nesbit avenue south; bloomington MN 55437
• Manufacturer Contact: dustin smith ; 10801 nesbit ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 6482706
• MDR Text Key: 72462347
• Report Number: 3004983210-2017-00014
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: MHTLGTH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention