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U.S. Department of Health and Human Services

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

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SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 90MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
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).
 
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Brand Name11.0MM TI HELICAL BLADE 90MM-STERILE
Type of DeviceROD,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 Key6707356
MDR Text Key79840280
Report Number3003506883-2017-10131
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received07/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2017
Device Catalogue Number456.303S
Device Lot Number5796011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/12/2017 Patient Sequence Number: 1
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