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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG (MDR) DELTA 1.7X4MM SCREW, 10 EA; IMPLANT
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STRYKER LEIBINGER FREIBURG (MDR) DELTA 1.7X4MM SCREW, 10 EA; IMPLANT Back to Search Results
Catalog Number 70-17104
Device Problems Component Falling (1105); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2015
Event Type  malfunction  
Event Description
A company representative was present during a cranial vault reconstruction in which delta screws had slight retention with the blade (delta 1.7), but would not load completely.The company representative tried a new screw driver blade and the screws still would not load with great retention.The surgery was delayed approximately 10 minutes while the surgeons were trying to problem solve the screws, and find screws that were falling off the blade into the surgical field.The company representative got a new lot of screws and these screws worked.
 
Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.Device is unavailable for return.
 
Manufacturer Narrative
Although the devices were not returned for investigation a previous complaint ((b)(4)) regarding the same failure mode and the same lot was investigated and can be applied to the current complaint: the inspection of the devices provided could confirm the reported event.It was not possible to pick-up 10 returned screws with a new sample blade (# 70-76271).In the visual inspection it was further determined that the screws do not show any damages.The returned screws were forwarded to the supplier ((b)(4)).The screws were measured and found to be within the specified values.The issue was discussed with the related r&d department and it is a known issue that in a worst case combination of the screw and the blade the specified dimensions of the screw and the related blades (70-71770 and 70-76271) can show a difficult pick-up ability.Therefore the complaint can be attributed to a design-related issue.Nc # (b)(4) was already opened for the previous complaint ((b)(4)) to further investigate/assess this issue.Actual device not returned but a device with the same failure mode and from the same lot was investigated.
 
Event Description
A company representative was present during a cranial vault reconstruction in which delta screws had slight retention with the blade (delta 1.7), but would not load completely.The company representative tried a new screw driver blade and the screws still would not load with great retention.The surgery was delayed approximately 10 minutes while the surgeons were trying to problem solve the screws, and find screws that were falling off the blade into the surgical field.The company representative got a new lot of screws and these screws worked.
 
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Brand Name
DELTA 1.7X4MM SCREW, 10 EA
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG (MDR)
boetzingerstr. 41
freiburg D-791 11
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG (MDR)
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
jonathan schell
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key4863594
MDR Text Key5812796
Report Number0008010177-2015-00136
Device Sequence Number1
Product Code MAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993061
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number70-17104
Device Lot Number2015020749
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/29/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2015
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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