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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 2.0X6MM, UPPERFACE, (5/PACKAGE); IMPLANT
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STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 2.0X6MM, UPPERFACE, (5/PACKAGE); IMPLANT Back to Search Results
Catalog Number 50-20906
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2015
Event Type  malfunction  
Event Description
It was reported that both bone screws being reported (product numbers 5020906 and 5020904) were kept in the facility's biopsy tray.The surgeon was securing the cannula to the cranium.The surgeon was attaching a burr hole cover (product # 5334510) using product # 5020906 to cover the defect.The head of product # 5020906 detached from the body of the screw.The surgeon then tried using product# 5020904, and the head of the screw detached from the body of the screw.The surgeon proceeded using regular neuro set.The sales representative was not there during the case, but he did confirm that mini-plating screwdriver blade 60-20140 was being used during the procedure.No adverse consequences nor significant delay were reported.
 
Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
 
Manufacturer Narrative
The product was returned for investigation and the reported event could be confirmed.The metallurgical investigation shows that the screw broke as a result of too high torsional forces in forced rupture mode during the turn out.The fracture surfaces show the typical flow structures of a ductile torsional breakage.A contributing factor to the failure could have been a very hard bone.The ifu recommends to drill a pilot hole in such cases to facilitate insertion.Furthermore, the plate that was used in combination with the complained screws is part of the universal neuro 3 system.The ifu states that universal neuro iii implants, instruments and accessories are produced and designed to be used together.The inner diameter of the plate holes is 2.2mm and the diameter of the complained screw is 2.0mm.The gap between the plate hole and the screw thread is very small and it is very difficult to turn-in the complained screw into the plate holes without abrasion / collision between the flanks of the screw and the lip of the plate.Most likely these pre-damages occurred and caused the breakages.Therefore the plate should not have been used with the complained screws.Summarizing the investigation the failure mode (intraoperative screw fracture) can be attributed to a user related event in terms of a misuse/off-label use.Based on the evaluation no indications for any design, material or manufacturing related problems were found in this investigation.
 
Event Description
It was reported that both bone screws being reported (product numbers 5020906 and 5020904) were kept in the facility's biopsy tray.The surgeon was securing the cannula to the cranium.The surgeon was attaching a burr hole cover (product # 5334510) using product # 5020906 to cover the defect.The head of product # 5020906 detached from the body of the screw.The surgeon then tried using product# 5020904, and the head of the screw detached from the body of the screw.The surgeon proceeded using regular neuro set.The sales representative was not there during the case, but he did confirm that mini-plating screwdriver blade 60-20140 was being used during the procedure.No adverse consequences nor significant delay were reported.
 
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Brand Name
BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 2.0X6MM, UPPERFACE, (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
kelli dykstra
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key4651344
MDR Text Key19819228
Report Number0008010177-2015-00064
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 Other,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/13/2015
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 Number50-20906
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/13/2015
Initial Date FDA Received04/02/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/11/2015
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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