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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 9MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 9MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.945S
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). 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 germany as follows: it was reported that a trochanteric fixation nail-advanced (tfna) nail broke postoperatively. The nail was implanted on (b)(6) 2022. The patient was revised on an unknown date. The implant has been in patient for about 1. 5 months. No fragments were generated. No further information is provided. This report is for one (1) 9mm/130 deg ti cann tfna 235mm/left - sterile this is report 1 of 1 for complaint (b)(4).
 
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Brand Name9MM/130 DEG TI CANN TFNA 235MM/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 Key14600539
MDR Text Key293332884
Report Number8030965-2022-03702
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819651876
UDI-Public(01)07611819651876
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,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 Number04.037.945S
Device Lot Number554P381
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2021
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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