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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2020
Event Type  malfunction  
Manufacturer Narrative
510k: this report is for an unknown tfna nail/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6), 2020, the patient underwent the osteosynthesis surgery for femoral trochanteric fracture with the flexible screwdriver and nail in question. During the surgery, the surgeon tried to work the locking mechanism of the nail with the screwdriver, but he had difficulty in working it and it took ten minutes. The surgery was completed successfully with ten minutes surgical delay. Patient outcome is reported as stable. No further information is available. Concomitant device reported: 5mm hex flexible screwdriver (part # 03. 037. 028, lot # unknown, quantity 1) this report is for one unknown tfna nail this is report 2 of 2 for complaint (b)(4).
 
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Brand NameUNK - NAILS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10861870
MDR Text Key240930789
Report Number8030965-2020-09026
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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