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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXNEURO SCREW SELF-DRILLING 4MM; SCREW, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXNEURO SCREW SELF-DRILLING 4MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 04.503.104.04S
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2018
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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.A device history record review has been requested.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 the patient underwent an unknown surgery on (b)(6) 2018.During the surgery, one (1) self drilling matrixneuro screw could not be drilled into the patient's bone.The surgery was completed without surgical delay.Patient outcome was stable.This report is for a titanium (ti) matrixneuro screw.This is report 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.Sterile part 04.503.104.04s, lot l874080: manufacturing location: selzach.Supplier: frueh ag.Release to warehouse date: april 27, 2018.Expiry date: april 01, 2028.Non-sterile part 04.503.104.20, lot h540866: manufacturing location: monument.Manufacturing date: january 09, 2018.A was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A product investigation was completed: microscopic investigations show that the tip of the screw is flattened and the thread is plastically deformed post production.The visible signs clearly indicate strong contact with hard bone during insertion.As result of this damage it was not possible to insert the screw as intended.Also, the cruciform recess at the screw head is deformed what indicates high applied mechanical force while insertion as well.As these screws are very small and quite fragile, a lot of care is required while handling.We can confirm the visible damages are not from any manufacturing non-conformity.The complaint condition can be replicated with the returned device.Because of the deformation the insertion of the screw was not possible.Due to the damages, no dimensional check can be performed.No product fault could be identified.The visible damages which resulted in the complaint condition are caused post-manufacturing by the user while insertion.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.Additional narrative: event: additional information provided.Device evaluated by mfr: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Corrected data: concomitant medical products, device evaluated by mfr.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
The surgery was completed using an alternative screw of the same type.
 
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
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8105858
MDR Text Key128425190
Report Number8030965-2018-58486
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07611819901643
UDI-Public(01)07611819901643
Combination Product (y/n)N
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 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.503.104.04S
Device Lot NumberL874080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Date Manufacturer Received01/17/2019
Patient Sequence Number1
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