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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; SCREW, FIXATION, INTRAOSSEOUS
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SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; SCREW, FIXATION, INTRAOSSEOUS Back to Search Results
Model Number 04.503.206.01
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2022
Event Type  malfunction  
Event Description
Device report from uruguay reports an event as follows: it was reported that on (b)(6) 2022, while placing the cortical screws in question they would fragment and disintegrate.When force was applied to the screws, they would break apart without providing any resistance at all.No further information available.This report is for a ti matrixmidface screw self-tapping 6mm.This is report 3 of 9 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional procode: jey.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.
 
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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
 
Event Description
There was no surgical delay.The procedure was successfully completed.The patient is in good condition.
 
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.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.Manufacturing location: monument manufacturing date: 09-jun-2022 part number: 04.503.206.01c, ti matrixmidface screw self-tapping 6mm lot number: 876p942 (non-sterile) lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection, ns033885 rev ae met all inspection acceptance criteria.Packaging label log (pll) lmd rev ae was reviewed and determined to be conforming.Packaging bom was reviewed and determined 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.Component part(s) reviewed: part number: 21015, tialnbri4.00 lot number: 189p289 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated 28-apr-2021 was reviewed and determined to be conforming.Lot summary report dated 17-jun-2021 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
Type of Device
SCREW, FIXATION, INTRAOSSEOUS
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 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15538014
MDR Text Key305242461
Report Number8030965-2022-07800
Device Sequence Number1
Product Code DZL
UDI-Device Identifier10887587018812
UDI-Public(01)10887587018812
Combination Product (y/n)N
Reporter Country CodeUY
PMA/PMN Number
K050608
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number04.503.206.01
Device Catalogue Number04.503.206.01C
Device Lot Number876P942
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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