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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.000S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on an unknown date, the patient underwent the open reduction internal fixation surgery for trochanteric fracture of femur with the tfna implants in question.The surgery was completed successfully without any surgical delay.After the surgery, non-union was confirmed on an unknown date.Therefore, the revision surgery to dhs plate was performed on (b)(6) 2019.The surgery was completed successfully without any surgical delay.The surgeon reported that non-union was caused by the difficulty in sliding after surgery due to the use of nail inconsistent with the neck-shaft angle, and reported that dhs should have been used for the initial surgery.No further information is available.Concomitant device reported: unk plate (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) tfna end cap extens.0 tan this is report 3 of 4 for complaint.
 
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(6) medical center.(b)(6) japan, (b)(6) japan.Reporter is a j&j employee.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 Name
TFNA END CAP EXTENS. 0 TAN
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 4436
SZ   4436
MDR Report Key14806718
MDR Text Key295033368
Report Number8030965-2022-04328
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819648708
UDI-Public(01)07611819648708
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number04.038.000S
Device Lot Number9212090
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/30/2022
Initial Date FDA Received06/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK PLATE
Patient Outcome(s) Required Intervention;
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