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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.012S
Device Problem Device-Device Incompatibility (2919)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/21/2022
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation, but has yet to be received. 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 synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent an open reduction internal fixation for trochanteric fracture of femur. The surgeon planned on using a 10 mm trochanteric fixation nail advanced (tfna) nail. However, due to the influence of the patient's bone quality and the entry point of the nail, it became difficult to insert the nail. The surgeon drilled the medullary cavity with a reamer for blades, but the nail could not be inserted. The nail was replaced with a 9-mm diameter nail and that was able to be inserted. The surgeon also had difficulty putting in the end cap. The surgery was completed with a less than thirty (30) minute delay and increased bleeding. The patient condition was reported stable. This report is for a tfna nail. This is report 1 of 2 for (b)(4).
 
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Brand Name10MM/125 DEG TI CANN TFNA 170MM - 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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13560436
MDR Text Key289349610
Report Number8030965-2022-00996
Device Sequence Number1
Product Code HSB
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,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.012S
Device Lot Number62P9241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/18/2022 Patient Sequence Number: 1
Treatment
UNK - END CAPS: TFNA; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - REAMERS
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