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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 115MM ROD,FIXATION,INTRAMEDULLARY

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SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 115MM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 456.308
Device Problem Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  malfunction  
Manufacturer Narrative
Patient identifier, age or date of birth, and weight are not available for reporting. Additional code: hwc. Device was not implanted or explanted. Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. 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 patient underwent a trochanteric fixation nail (tfn) procedure for intertrochanteric hip fracture on (b)(6) 2017. Upon insertion of helical blade through the nail, it was noticed that the plunger built into the nail was advanced, preventing the helical blade from passing through the nail. The surgeon pulled the plunger backed up and continued to insert helical blade but it would not advance. He repositioned guide wire and attempted one more time with same results, the helical blade would not advance. It was determined best to remove the nail and helical blade that was not advancing and replaced it with another of the same size. The surgery was completed successfully with a time delay of 15 minutes because of the attempts, removal, reassembly and reinsertions. There was no harm to patient and the patient outcome is not available. This report is for one (1) helical blade. This is report 2 of 2 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. A device history record review was performed for the subject device lot number. Manufacturing location: (b)(4). Date of manufacture/release to warehouse date: apr 24, 2014. The review of the device history record revealed no complaint related anomalies. The device history record shows this lot of 11. 0 ti helical blade 115mm 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name11.0MM TI HELICAL BLADE 115MM
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 Key6460810
MDR Text Key71917931
Report Number3003506883-2017-10052
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,Followup
Report Date 03/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.308
Device Lot Number7661091
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 Received04/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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