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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM PLATE, FIXATION, BONE

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SYNTHES GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.210.120
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Event Description
Device report from (b)(6) reports an event as follows: it was reported that patient was treated on (b)(6) 2022, for trauma following a road accident, in particular presenting fracture of the right wrist, treated by osteosynthesis. When placing a distal radius plate, the surgeon noticed that the screw passed through the plate without locking. The defective screw was removed, and another screw was used without difficulty. The stability control of the assembly was satisfactory in peri-op. Procedure was completed successfully with no delay. There was no patient consequence. This report is for a 2. 4mm ti va locking screw stardrive 20mm. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: additional procode: hwc. 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. 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.
 
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Brand Name2.4MM TI VA LOCKING SCREW STARDRIVE 20MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13518203
MDR Text Key286493184
Report Number8030965-2022-00856
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
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 Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.210.120
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/11/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWDRIVERS; VA-LCP-2-COLUMN DRP2.4 VOLAR NARR R SHAF
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