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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 03.037.026
Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for trochanteric fracture of femur. Before surgery, a nurse assembled the instrument and implant in question. During the process of setting the devices, they got stuck and could not be disassembled. Another nurse disassembled them by force. After disassembly, it was found that the coupling screw was wrapped with sticky material (like gray tape). As foreign matter was seen in the middle abdomen after checking the inner space of the helical blade inserter, re-washing and re-sterilization were performed immediately before the surgery. The surgery proceeded with no problem and was completed with no surgical delay. The patient outcome was reported as stable. No further information is available. This report is for one (1) helical blade/screw coupling screw. This is report 2 of 2 for (b)(4).
 
Manufacturer Narrative
Additional narrative: complainant part is 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. 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.
 
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Brand NameHELICAL BLADE/SCREW COUPLING SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13021694
MDR Text Key287341376
Report Number8030965-2021-10289
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
Treatment
TFNA HELICAL-BLADE IMPACT
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