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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE); IMPLANT
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STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE); IMPLANT Back to Search Results
Catalog Number 50-20410
Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/28/2014
Event Type  malfunction  
Event Description
During surgery surgeon was using a 4 hole curved plate with the correct screw and the correct drill bit.The screw was about 80% to 90% in and the screw head broke off.The shaft of the screw was left in the patient.
 
Manufacturer Narrative
Investigation in progress but not yet complete.
 
Manufacturer Narrative
The reported event could be confirmed.The investigation results showed that the screw broke as a result of too high torsional forces in forced rupture mode during the insertion.The fracture surface shows the typical flow structures of a ductile torsional breakage.The root cause of the failure was that after the screw contacted the plate, it was forcibly further turned.No indications were found for any material or manufacturing related issue.
 
Event Description
During surgery surgeon was using a 4 hole curved plate with the correct screw and the correct drill bit.The screw was about 80% to 90% in and the screw head broke off.The shaft of the screw was left in the patient.
 
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Brand Name
BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE)
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-79 111
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-79 111
Manufacturer Contact
jamshed badarpura
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key3830544
MDR Text Key4402003
Report Number0008010177-2014-00132
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/28/2014
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
Device Catalogue Number50-20410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/28/2014
Initial Date FDA Received05/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/19/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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