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 Problems Arthritis (1723); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight wasn¿t provided for reporting.Date of event is unknown.Additional device product code: hwc.(b)(4).Initial implant procedure was sometimes in 2008.Exact date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 456.303s, lot# 5796011.Manufacturing location: (b)(4), release to warehouse date: jun 13, 2008, expiry date: may 31, 2017.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0 mm ti helical blade 90 mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release 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 non-conformance noted.This raw material 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.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 report that the patient had original surgery sometime in 2008 for treatment of a proximal femur fracture, where the trochanteric fixation nail system was used.Patient was implanted with one (1) cannulated trochanteric fixation nail, one (1) helical blade implant and one (1) distal locking screw.On an unknown date, post-operative, patient presented with pain, arthritis and avascular necrosis (avn) of the femur head.On (b)(6) 2017, surgeon removed all implants and revised the patient to a depuy total hip replacement.It was reported that no fragments were generated during implant removal.Removed implants were reported in good condition with no issues.All implants have been retained by the hospital.Revision surgery was completed successfully with no time delay.Patient was reported in stable condition.This report is for one (1) ti helical blade 90 mm-sterile.This is report 2 of 3 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6707356
• MDR Text Key: 79840280
• Report Number: 3003506883-2017-10131
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 456.303S
• Device Lot Number: 5796011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention