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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS: TFNA

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SYNTHES GMBH UNK - END CAPS: TFNA Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - end caps: tfna/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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
It was reported that on (b)(6) 2021, the patient underwent revision surgery due to the tfna was being removed due to nonunion/ malunion. The surgery was successfully completed. The patient outcome is unknown. This complaint involves four (4) devices. This report is for (1) unk - end caps: tfna. This is report 4 of 4 or complaint (b)(4).
 
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Brand NameUNK - END CAPS: TFNA
Type of DeviceUNK - END CAPS: TFNA
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 Key12990227
MDR Text Key286247236
Report Number8030965-2021-10176
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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 Received12/13/2021
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 Received01/10/2022
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: 12/13/2021 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
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