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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG L-PLATE, 100 DEGREE, 12MM BAR, LEFT, STANDARD, 6 HOLE, MIDFACE; IMPLANT
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STRYKER LEIBINGER FREIBURG L-PLATE, 100 DEGREE, 12MM BAR, LEFT, STANDARD, 6 HOLE, MIDFACE; IMPLANT Back to Search Results
Catalog Number 55-06766
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
Event Description
It was reported by a company representative that during a lefort fracture procedure when drilling into a plate hole the drill bit broke off the bottom lower part of the plate.The surgeon cut the damaged area off of the plate.There are no additional details available.
 
Event Description
It was reported by a company representative that during a lefort fracture procedure when drilling into a plate hole the drill bit broke off the bottom lower part of the plate.The surgeon cut the damaged area off of the plate.There are no additional details available.
 
Manufacturer Narrative
Because the affected device was not returned a confirmation of the reported event is not applicable.Further information was requested several times in order to gain more insight in the reported event.No lot number could be provided for the plate in question.No drill guide were used during the procedure.Further, as stated in the event description, only a hole from the affected plate was damaged.The surgeon cut off the damaged hole and still implanted the plate.Unfortunately the impaired hole was discarded post surgery and could not be returned to freiburg for investigation.Based on statistical evaluation there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.If the device will be returned, the investigation will be reopened.
 
Manufacturer Narrative
Because the affected device was not returned a confirmation of the reported event is not applicable.Further information was requested several times in order to gain more insight in the reported event.No lot number could be provided for the plate in question.No drill guide were used during the procedure.Further, as stated in the event description, only a hole from the affected plate was damaged.The surgeon cut off the damaged hole and still implanted the plate.Unfortunately the impaired hole was discarded post surgery and could not be returned to freiburg for investigation.Based on statistical evaluation there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.If the device will be returned, the investigation will be reopened.
 
Event Description
It was reported by a company representative that during a lefort fracture procedure when drilling into a plate hole the drill bit broke off the bottom lower part of the plate.The surgeon cut the damaged area off of the plate.There are no additional details available.
 
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Brand Name
L-PLATE, 100 DEGREE, 12MM BAR, LEFT, STANDARD, 6 HOLE, MIDFACE
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
MDR Report Key7365855
MDR Text Key103552241
Report Number0008010177-2018-00028
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
PMA/PMN Number
K022185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/12/2018
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 Number55-06766
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/14/2018
Initial Date FDA Received03/23/2018
Supplement Dates Manufacturer Received03/14/2018
Supplement Dates FDA Received07/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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