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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
510k: this report is for an unknown nail head elements: tfn helical blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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, during a proximal femur osteosynthesis using an intertrochanteric nail, at the time of placing the spiral blade, the surgeon used the hammer for impactions, which caused the head of the connecting screw to break. The surgeon was unable to remove the screw from the blade and decided to remove the blade again by hitting the insertion arc. The blade was removed, and the procedure was continued. The arch wire was already damaged by the impactions. The drill guide was placed for the distal locking of the nail, and this hole through which the drill guide sleeve passes is not in good condition. The sleeve entered the hole, and the drilling was made for the distal locking of the nail. The procedure was completed successfully. No patient consequence reported. Concomitant devices reported: unknown tfn nail (part # unknown, lot # unknown, quantity 1), unknown hammer (part # unknown lot # unknown, quantity 1), unknown tfn helical blade (part # unknown, lot # unknown, quantity unknown), unknown hammer (part # unknown, lot # unknown, quantity unknown). This report is for one (1) unk - nail head elements: tfn helical blade. This is report 5 of 6 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10818081
MDR Text Key215606458
Report Number8030965-2020-08814
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
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 Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/10/2020 Patient Sequence Number: 1
Treatment
AIM-ARM F/TFN 130°; BUTTRESS/COMPR-NUT F/357.369; CONNECSCR F/HELICAL BLADE F/TFN; GUIDE SLEEVE F/HELICAL BLADE F/TFN; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NAILS: TFN
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