MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 120MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.309

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient¿s height reported as (b)(6).Additional device product code: hwc (b)(4).Lot number unknown.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that a trochanteric femoral nail (tfn) removal and revision was performed on (b)(6) 2017.The date of the original procedure is unknown.Subsequently on an unknown date, the patient sustained a fall and fractured below the original tfn site.Removed hardware included: the nail, a helical blade and a locking ¿bolt¿, all removed fully intact.The patient was revised to long trochanteric nail.The original fracture site was fully healed and the nothing untoward occurred during the removal/revision procedure.The procedure was completed successfully with the patient in stable condition.This report is for one (1) 11.0mm ti helical blade 120mm this is report 2 of 3 for complaint (b)(6).

• Brand Name: 11.0MM TI HELICAL BLADE 120MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6901341
• MDR Text Key: 87733086
• Report Number: 3003506883-2017-10221
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 456.309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 132