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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW FIXATION INTRAOSSEOUS
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW FIXATION INTRAOSSEOUS Back to Search Results
Model Number 201.932
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 08/04/2018
Event Type  Injury  
Manufacturer Narrative
Patient weight is unknown.Device broke during insertion; device not considered implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes sales consultant.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that during a cerclage procedure on (b)(6) 2018, the head of an intermaxillary fixation (imf) screw was broken.The body of the imf screw was already in the patient's bone however the screw head remained outside the bone and was impossible to remove.The screw body was left in the patient's bone and to prevent the patient from experiencing pain, the surgeon used the reamers to have the broken screw be at the same level with the patient's bone.There was a surgical delay of ten to fifteen minutes.Patient outcome was reported as normal.The surgical procedure was successfully completed.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: 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 history lot, device history batch, device history review null.Product status was changed from received to customer retaining product, it was not received at the warehouse.Device was used for treatment, not diagnosis.
 
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Brand Name
2.0MM IMF SCREW SELF-DRILLING 12MM
Type of Device
SCREW FIXATION INTRAOSSEOUS
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7798326
MDR Text Key117627224
Report Number8030965-2018-55824
Device Sequence Number1
Product Code DZL
UDI-Device Identifier20887587028658
UDI-Public(01)20887587028658
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 08/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number201.932
Device Catalogue Number201.932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2018
Date Manufacturer Received01/03/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 YR
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