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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LOCKSCR Ø5 SELF-TAP L44 TAN; APPLIANCE, FIXATION, NAIL
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OBERDORF SYNTHES PRODUKTIONS GMBH LOCKSCR Ø5 SELF-TAP L44 TAN; APPLIANCE, FIXATION, NAIL Back to Search Results
Catalog Number 412.216S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a surgery with a femoral neck system (fns).On (b)(6) 2019, the patient fell, the hospital confirmed that the subtrochanteric fracture occurred.No further information is available.This report is for one (1) lockscr ø5 self-tap l44 tan.This is report 4 of 4 for pc-(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: h3, h4, h6: 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.H3, h6- product was not returned.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.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
LOCKSCR Ø5 SELF-TAP L44 TAN
Type of Device
APPLIANCE, FIXATION, NAIL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9262872
MDR Text Key176342520
Report Number8030965-2019-69897
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
PMA/PMN Number
K000682
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 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number412.216S
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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