MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 90MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.303S

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

Patient Problem Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation; it was noted the device was discarded.Manufacture date: january 28, 2015.Expiration date: december 31, 2023.A review of the device history record revealed no complaint related anomalies.The device history record shows this device was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no anomalies noted.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 planned revision of a trochanteric fixation nail (tfn) due to irritation took place on (b)(6) 2016.The tfn was implanted on an unknown date.After implantation the patient began to experience irritation on an unknown date.During the revision the blade was explanted intact without difficulty or delay, and replaced with an 85mm tfn lag screw.The remainder of the implants placed in the original surgery remained implanted.The surgery was successful with no patient harm or surgical delay.The patient condition was reported as successful.This is report 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 90MM-STERILE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5457621
• MDR Text Key: 38963184
• Report Number: 3003506883-2016-10040
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011857
• 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: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 456.303S
• Device Lot Number: 7897632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention