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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS Back to Search Results
Catalog Number 201.928
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 01/03/2019
Event Type  malfunction  
Manufacturer 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2019, during a right pelvi-glosso-mandibulo surgery, right cervical and the reconstruction by free flap of the fibula, the intermaxillary fixation (imf) screw broke during imf screw implantation.The body of the screw was retained inside the patient¿s bone and the head of the screw was retained on the screwdriver.The imf screw was changed to complete the procedure and the foreign material remained on the patient bone.There was a surgical delay of an unknown number of minutes due to the reported event.The patient was discharged.Concomitant device reported: screwdriver handle medium with quick coupling (part #: 311.42, lot #: 9825549, quantity: 1), holding sleeve (part #: 313.97, lot #: unknown, quantity: 1), screwdriver shaft (part #: 314.448, lot #: 9841748, quantity: 1).This complaint involves one (1) device.This report is 1 of 1 for (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.Additional narrative: h3, h4, h6- visual inspection: the thread is broken off about 3.5mm below the head.The broken part is missing.Dimensional inspection: the relevant feature is deformed in a manner which prevents accurate measurement of the feature.Summary: the complaint is confirmed as the received imf screw is broken as complained.The view of the fracture face and the deformations at the cruciform recess indicate that the screw was exposed to too much torque during the insertion.This did lead to a mechanical overload and finally the breakage of the device.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.
 
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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
2.0MM IMF SCREW SELF-DRILLING 8MM
Type of Device
SCREW FIXATION INTRAOSSEOUS
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8303012
MDR Text Key134969709
Report Number8030965-2019-60625
Device Sequence Number1
Product Code DZL
UDI-Device Identifier07611819724358
UDI-Public(01)07611819724358
Combination Product (y/n)N
PMA/PMN Number
K010527
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number201.928
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Date Manufacturer Received03/07/2019
Patient Sequence Number1
Treatment
SEE EVENT DESCRIPTION.
Patient Age71 YR
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