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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 Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Additional device product code: hwc. (b)(4). The reported lot number, 7811650, could not be validated as belonging to the reported part number. Patient was implanted in 2016 about six to eight months (6-8) ago, exact date was unknown device is not expected to be returned for manufacturer review/investigation. 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 patient was originally implanted with a 11. 0mm/130 degree titanium trochanteric fixation nail (tfn) left, a 11. 0mm titanium helical blade, and an unknown 5. 0mm locking screw on an unknown date on about six to eight months (6-8) ago to repair a left femur fracture. On (b)(6) 2016, the patient was returned to the operating room in to remove the devices after it was identified that the patient presented with a non-union. The complained devices were successfully removed and the patient was implanted with a 6 hole dynamic hip screw (dhs) and an unknown number of unknown screws. The surgery was successfully completed without any surgical delay and no adverse events were reported against the patient. This is report 2 of 3 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis a review of the device history records has been completed. Lot 7811650 corresponds with 456. 303s. Part mfg date: october 17, 2014 part exp. Date: september 30, 2023 location:(b)(4). A review of the device history record revealed no complaint related anomalies. The device history record shows this lot of 11. 0mm ti helical blade 90mm sterile product was processed through the normal manufacturing and inspection operations with no rework or non-conformities 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 but there was a non-conformance noted, ncr#(b)(4). This ncr was for documentation, the original vendor supplied certified test report had the calculated beta transus temperature listed in degrees fahrenheit. This was corrected to degrees celsius and the lot of material was accepted. 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. (b)(4). 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 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 Key6110204
MDR Text Key60242958
Report Number2520274-2016-15432
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 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number456.303S
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 Received12/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2014
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: 11/17/2016 Patient Sequence Number: 1
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