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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 85MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA FENESTRATED SCREW 85MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.185
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the surgeons had to remove a trochanteric fixation nail-advanced (tfna) system due to the broken proximal and distal screws. No further information is provided. During manufacturer's investigation of the returned devices it was identified that tfna fenestrated screw 85mm is broken. This device condition was evaluated and determined to be reportable on (b)(6) 2021. This report is for one (1) tfna fenestrated screw 85mm. This is report 3 of 3 for complaint (b)(4).
 
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Brand NameTFNA FENESTRATED SCREW 85MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11485874
MDR Text Key250358399
Report Number8030965-2021-01959
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.185
Device Lot NumberH869164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/18/2019
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: 03/15/2021 Patient Sequence Number: 1
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