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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH TIBIAL ALIGNMENT ROTATION SLEEVE STAR ANKLE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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STRYKER GMBH TIBIAL ALIGNMENT ROTATION SLEEVE STAR ANKLE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Catalog Number 9330003
Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported that the star implant item on the tibial alignment guide was broken.The screw on the sliding block on the proximal end had been sheared and left in the guide, this meant it was unable to be used.Another item was used to complete the case.
 
Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, most probably the failure was caused by inappropriate device maintenance/handling and device useful life exceedance.The reported event occurred in 2019 and the device was manufactured on 02-nov-2011, meaning that it has been in working order for almost 8 years, a significant amount of time.The useful life of re-usable medical devices depends on many factors, including the method and duration of each use and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.The cleaning and sterilization guide clearly mentions that " stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date.Before preparing for sterilization, all medical devices should be inspected.Generally un-magnified visual inspection under good light conditions is sufficient.All parts of the devices should be checked for visible soil and/or corrosion.'' therefore, this case is classified as a user related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
It was reported that the star implant item on the tibial alignment guide was broken.The screw on the sliding block on the proximal end had been sheared and left in the guide, this meant it was unable to be used.Another item was used to complete the case.
 
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Brand Name
TIBIAL ALIGNMENT ROTATION SLEEVE STAR ANKLE
Type of Device
PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8947011
MDR Text Key161701814
Report Number0008031020-2019-01193
Device Sequence Number1
Product Code NTG
UDI-Device Identifier00886385018812
UDI-Public00886385018812
Combination Product (y/n)N
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9330003
Device Lot Number1325302
Was Device Available for Evaluation? No
Date Manufacturer Received11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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