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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS: TFNA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH UNK - END CAPS: TFNA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/21/2022
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown end cap/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. 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 an unknown end cap. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - END CAPS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13560473
MDR Text Key288205482
Report Number8030965-2022-00997
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
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/18/2022 Patient Sequence Number: 1
Treatment
TFNA FEM NAIL Ø10 125° L170 TIMO15; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - REAMERS
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