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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number UNK_INS
Device Problems Vibration (1674); Fitting Problem (2183)
Patient Problem Bone Fracture(s) (1870)
Event Date 12/04/2020
Event Type  Injury  
Event Description
It was reported that during a total ankle replacement procedure, while the surgeon was making a cut, the blade moved from side to side more than normal in the handpiece saw.It was also reported that the fibula was accidently fractured.It was further reported that the surgeon fixed the fracture with a cannulated screw and a plate.It was further reported that there was a 45 minute delay as a result of this event and the procedure was completed successfully.
 
Event Description
It was reported that during a total ankle replacement procedure, while the surgeon was making a cut, the blade moved from side to side more than normal in the handpiece saw.It was also reported that the fibula was accidently fractured.It was further reported that the surgeon fixed the fracture with a cannulated screw and a plate.It was further reported that there was a 45 minute delay as a result of this event and the procedure was completed successfully.
 
Manufacturer Narrative
Supplemental report submitted to document complaint investigation results.H3 other text: device not returned for evaluation.
 
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Brand Name
UNKNOWN_INSTRUMENTS_PRODUCT
Type of Device
INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11097738
MDR Text Key224519959
Report Number0001811755-2020-03616
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_INS
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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