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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.158S
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
It was repotted that a patient came in on may 6, 2022 for revision surgery due to broken trochanteric fixation nail-advanced (tfna) nail. The nail was found broken at the lag screw insertion site during a follow up hip x-ray. The nail was originally implanted on (b)(6) 2022. The procedure was successfully completed without any surgical delay. No further information provided. This report is for one (1) 11mm/130 deg ti cann tfna 380mm/right - sterile. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Additional patient identifier reported as (b)(6). Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j sales representative. Health effect clinical code (b)(4) used to capture code injury. A device history record (dhr) review was conducted: manufacturing location: (b)(4), manufacturing date: 04-mar-2020, expiration date: 01-feb-2030, part number: 04. 037. 158s, 11mm/130 deg ti cann tfna 380mm/right- sterile, lot number: 44p6116 (sterile), lot quantity: (b)(4). One piece was scrapped in cell, for a functional failure. Production order traveler met all inspection acceptance criteria apart from the one piece noted. Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria apart from the one piece noted. Inspection sheet, tfna assembly inspection met all inspection acceptance criteria. Packaging label log (pll) lmd was reviewed and determined to be conforming. Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified. Scn was reviewed and determined to be conforming. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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 Name11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key14600073
MDR Text Key293335298
Report Number8030965-2022-03697
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819650626
UDI-Public(01)07611819650626
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 Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.158S
Device Lot Number44P6116
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/04/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

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