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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: LOCKING; SCREW,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: LOCKING; SCREW,FIXATION,BONE Back to Search Results
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2020
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown screw: locking /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during the placement of the expert retrograde/antegrade femoral nail (rafn), when attempting to remove the proximal lateromedia locking screw the screwdriver broke.The tip became deformed.Another screwdriver was used to remove the screw.The procedure was completed successfully.There was no consequence to the patient.Concomitant device reported: expert rafn nail (part number unknown, lot unknown, quantity 1), inter-lock screwdriver combined t25/hexa (part number 03.010.472, lot 4l57868, quantity 1).This report involves (1) unknown locking: screw.Device became reportable as a malfunction on (b)(6) 2020.This is report 2 of 2 for (b)(4).
 
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Brand Name
UNK - SCREWS: LOCKING
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10344708
MDR Text Key201042045
Report Number8030965-2020-05478
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/09/2020
Initial Date FDA Received07/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
INTER-LOCK SCREWDRIVER COMBINED T25/HEXA; UNK - NAILS: RAFN
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