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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.259S
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/23/2022
Event Type  Injury  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was conducted: part#: 04. 037. 259s, synthes lot#: h873562, supplier lot#: n/a, release to warehouse date: 17 apr2019, manufactured by: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. Health effect clinical code (b)(4) used to capture code injury. 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.
 
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that a trochanteric fixation nail-advanced (tfna) nail broke postoperatively. No further information provided. This report is for one (1) 12mm/130 deg ti cann tfna 380mm/left-sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand Name12MM/130 DEG TI CANN TFNA 380MM/LEFT-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 Key14600447
MDR Text Key293336052
Report Number8030965-2022-03701
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819651357
UDI-Public(01)07611819651357
Combination Product (y/n)N
Reporter Country CodeSZ
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 Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.259S
Device Lot NumberH873562
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2019
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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