Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Consequences Or Impact To Patient (2199)
Event Date 01/09/2019
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on unknown date, an intermaxillary fixation (imf) screw fractured during margin mandibular insertion on (b)(6) 2019.The screw was removed after the fracture occurred.There was a twenty (20) minute surgical delay.The procedure was successfully completed with another unknown screw.All fragments were removed from the patient.There was no adverse consequence to the patient.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity 1).This report is for one (1) 2.0mm imf screw self-drilling 8mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the thread is broken off about 3.5mm below the head.The front piece of the thread was returned, the end of the piece is strongly damaged which was most likely caused during the extraction of the fragment.There are clearly visible deformations in clockwise direction at the cruciform recess visible.Material review: the lot number was not provided, therefore the material certificate cannot be reviewed.Typically are these device made out of 1.4441 stainless steel for surgical implants.The fracture face is homogenous, which indicates material conformity, and has the typical view of a forced rupture.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.These dates were inadvertently reported as 1/10/2019 in the initial report.The correct date is (b)(6) 2019.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8288657
MDR Text Key134463446
Report Number8030965-2019-60482
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 company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
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 Manufacturer01/28/2019
Date Manufacturer Received03/19/2019
Patient Sequence Number1
Patient Age45 YR
Patient Weight75
-
-