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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 2107-1015
Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2016
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted, upon completion of the investigation.
 
Event Description
The surgeon was using the 2107-1015 screwdriver from the trident set and the end of the screwdriver came off while tightening the screws inside the patient.Surgeon noticed this and was able to retrieve the piece from inside the shell.Surgeon was able to continue with the procedure with little delay to the operation.
 
Manufacturer Narrative
Returned to manufacturer on: 12/13/2016.An event regarding a fractured hexalobular screwdriver tip from a trident driver was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection of the returned device shows hexalobular tip of screwdriver was fractured.The fractured piece was included with the returned driver shaft.Deformation to the driver indicates the tip fractured while the device was being used to tighten a screw.-medical records received and evaluation: a review of medical records was not performed as none were provided.No further information was requested as there is no indication the failure was related to patient factors.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been two other events for the lot referenced.Conclusions: the reported event was confirmed as per visual inspection of the returned device which shows that the hexalobular tip of screwdriver was fractured.The fractured piece was included with the returned driver shaft.Deformation to the driver indicates the tip fractured while the device was being used to tighten a screw.The results of the design validation testing indicated that the tip remained susceptible to deformation at extreme angulations of the driver tip within the screw head.The design intent of the driver tip is to deform rather than to deform and/or break the screw (implant).
 
Event Description
The surgeon was using the 2107-1015 screwdriver from the trident set and the end of the screwdriver came off while tightening the screws inside the patient.Surgeon noticed this and was able to retrieve the piece from inside the shell.Surgeon was able to continue with the procedure with little delay to the operation.
 
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Brand Name
UNIVERSAL DRIVER SHAFT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
rita intorrella
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6179217
MDR Text Key62699200
Report Number0002249697-2016-03935
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K153345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/25/2017
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 Number2107-1015
Device Lot NumberF10M87331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/18/2016
Initial Date FDA Received12/15/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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