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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH MATRIX 1.1MM DRILL BIT J-LATCH/4MM STOP/44.5MM; DRILL, BONE, POWERED

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SYNTHES GMBH MATRIX 1.1MM DRILL BIT J-LATCH/4MM STOP/44.5MM; DRILL, BONE, POWERED Back to Search Results
Catalog Number 03.503.244
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2024
Event Type  malfunction  
Event Description
Device report from depuy synthes reports an event in italy as follows: it was reported that the device was ruptured preoperatively.There was no patient consequence.No further information is provided.This report is for one (1) matrix 1.1mm drill bit j-latch/4mm stop/44.5mm this is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that event occurred on an unknown date in (b)(6) 2024.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.
 
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Brand Name
MATRIX 1.1MM DRILL BIT J-LATCH/4MM STOP/44.5MM
Type of Device
DRILL, BONE, POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key18959676
MDR Text Key338366166
Report Number8030965-2024-03982
Device Sequence Number1
Product Code DZI
UDI-Device Identifier07611819901490
UDI-Public(01)07611819901490
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.503.244
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2024
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 Unknown
Patient Sequence Number1
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