MAUDE Adverse Event Report: SYNTHES (USA) 11.0MM TI HELICAL BLADE 100MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.305S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Irritation (1941); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient height is (b)(6).Additional device product code is hwc.Other number¿udi: (b)(4).(therapy date): unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 revision surgery including hardware removal and replacement was performed due to helical blade migration, patient pain and skin irritation.It is reported patient was implanted with a trochanteric femoral nail (tfn) and a 100mm helical blade on unknown date.The femoral head reduced as intended, causing the blade to back out.The patient reported pain from skin irritation where blade backed out.The patient was returned to surgery on (b)(6) 2017 where surgeon removed the helical blade and replaced it with an 80mm helical blade.The surgery was completed successfully with no delay and no harm to patient.Concomitant devices reported: trochanteric femoral nail (part number unknown, lot number unknown, quantity 1).This report is 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 100MM-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: 6376013
• MDR Text Key: 69014106
• Report Number: 2520274-2017-10718
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• 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
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.305S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2017
• 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: UNKNOWN TROCHANTERIC FEMORAL NAIL, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73