MAUDE Adverse Event Report: SYNTHES USA 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.161S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient weight not provided for reporting.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a hardware removal and revision was performed on (b)(6) 2016 due to a broken tfna.The original procedure to repair a left femur fracture was performed on (b)(6) 2015.Subsequently, it was discovered that the tfna had broken at the point of interface with the helical blade.The removed hardware included the broken tfna, one intact helical blade and one intact locking screw.The patient was revised to an oncologic total hip prosthesis.The procedure was completed successfully with the patient in stable condition.This complaint involves one device concomitant devices reported: helical blade (part #04.038.305s, lot #unknown, quantity 1), locking screw (part #04.005.540, lot #unknown, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6198795
• MDR Text Key: 63106252
• Report Number: 2520274-2016-15747
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.161S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HELICAL BLADE 04.038.305S,LOT UNK QTY 1; LOCKING SCREW PART #04.005.540, LOT UNK QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR