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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GOUGE W/10 L205/90; GOUGE, SURGICAL, GEN & PLASTIC SURGERY
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OBERDORF SYNTHES PRODUKTIONS GMBH GOUGE W/10 L205/90; GOUGE, SURGICAL, GEN & PLASTIC SURGERY Back to Search Results
Catalog Number 399.680
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
Device report from (b)(6) reports an event as follows: it was reported that during a femur procedure on an unknown date, the extraction screw broke.Femur nail and hip screws has already been implanted.Procedure was completed successfully with a surgical delay of fifteen (15) minutes.Patient status is unknown.This report is for a hollow gouge for broken screw exposure.This is report 1 of 3 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.Complained issue could not be replicated and/or confirmed based on the available information (incl.Pictures and/or x-ray¿s).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 (information or/and material), the investigation will be updated as applicable.Device history part: 399.680, lot: 5937986, manufacturing site: salzburg, release to warehouse date: 08.April 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.G5: device is not distributed in the united states but is similar to device marketed in the usa.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
 
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.H3, h4, h6- the visual inspection of the returned gouge instrument has shown that a piece of the tip section is broken off.The broken off piece was returned for investigation.The instrument is all in all in very used condition and there are clearly wear marks and scratches on the tip visible.Due to the strongly damages the relevant dimension could not be measured.However the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The received condition of the gouger instrument is concordant with the complaint description and the complaint condition is confirmed.This lot was manufactured in april 2016 according to the specification.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production criteria¿s.Unfortunately the exact cause which has led to the breakage could not be evaluated, based on the visual damages on the tip section we have to assume that a mechanical overload situation has led to the breakage.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 history lot part: 399.680, lot: 5937986, manufacturing site: salzburg, release to warehouse date: 08.April 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.,part: 399.680, lot: 5937986, manufacturing site: salzburg, release to warehouse date: 08.April 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
GOUGE W/10 L205/90
Type of Device
GOUGE, SURGICAL, GEN & PLASTIC SURGERY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9553567
MDR Text Key194113753
Report Number8030965-2020-00055
Device Sequence Number1
Product Code GDH
UDI-Device Identifier07611819028012
UDI-Public(01)07611819028012
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number399.680
Device Lot Number5937986
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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