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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM-4PK; SCREW, FIXATION, INTRAOSSEOUS
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TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM-4PK; SCREW, FIXATION, INTRAOSSEOUS Back to Search Results
Catalog Number 04.503.226.04C
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional device product code: jey.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a distributor.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 synthes reports an event in (b)(6) as follows: it was reported that when the distributor opened the package (before putting the screw into the tray), it was noted that the screw's cap was deformed.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) ti matrixmidface screw self-drilling 6mm-4pk.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: 9.Date device returned to manufacturer.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 manufacturing evaluation found evidence to support the complaint condition.The complaint device was missing the required cross slot feature and instead had two parallel slots.Device history lot : manufacturing location: monument, manufacturing date: 21-jul-2020, part number: 04.503.226.04c, ti matrixmidface screw self- drilling 6mm, lot number: 63p5035 (non-sterile).Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿screw cap deformed¿ does not indicate breakage of the screw.Therefore, review of the raw material would not be pertinent to the reported complaint condition.This is a confirmed complaint 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.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 MATRIXMIDFACE SCREW SELF-DRILLING 6MM-4PK
Type of Device
SCREW, FIXATION, INTRAOSSEOUS
MDR Report Key12423214
MDR Text Key269835427
Report Number8030965-2021-07494
Device Sequence Number1
Product Code DZL
UDI-Device Identifier07611819908581
UDI-Public(01)07611819908581
Combination Product (y/n)N
PMA/PMN Number
K083388
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup,Followup
Report Date 08/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.503.226.04C
Device Lot Number63P5035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2020
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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