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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA FENESTRATED SCREW 105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.205
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that a patient was implanted with trochanteric fixation nail-advanced (tfna) system on (b)(6) 2021. Patient experienced the post-op pain. X-ray taken on an unknown date identified that a cephalic screw is broken. On (b)(6) 2022 the patient underwent the nail extraction and total hip replacement procedure. No further information provided. This report is for one (1) tfna fenestrated screw 105mm. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Additional device product code: ktt. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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.
 
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Brand NameTFNA FENESTRATED SCREW 105MM
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
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key14640697
MDR Text Key293635491
Report Number8030965-2022-03818
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819659766
UDI-Public(01)07611819659766
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.205
Device Lot Number30P7097
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2019
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/09/2022 Patient Sequence Number: 1
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