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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM) INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM) INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 6425127105
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete. Device was discarded.
 
Event Description
It was reported that, during a tka (total knee arthroplasty) , when a nurse was opening the package, she noticed a pinhole on it. It was also reported that there were no adverse consequences and no delays as a result of this event. It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
The quality investigation is complete.
 
Event Description
It was reported that, during a tka (total knee arthroplasty) , when a nurse was opening the package, she noticed a pinhole on it. It was also reported that there were no adverse consequences and no delays as a result of this event. It was further reported that the procedure was completed successfully.
 
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Brand NameSTRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM)
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
NA
Manufacturer Contact
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
  NA
214532900
MDR Report Key9866827
MDR Text Key184732876
Report Number0001811755-2020-00752
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6425127105
Device Catalogue Number6425127105
Device Lot Number18200017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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