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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION STRYKER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER CORPORATION STRYKER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 7203026000
Device Problems Break (1069); Entrapment of Device (1212); Mechanical Problem (1384); Unintended Movement (3026)
Patient Problem Insufficient Information (4580)
Event Date 08/27/2021
Event Type  malfunction  
Event Description
During orthopedic procedure, wire driver attachment failed to release k-wire during positioning of orthopedic plate causing wire to continue spinning and break off in the plate and bone.Intervention required to remove broken wire.Removed wire driver from drill set and gave to supervisor.Manufacturer response for wire driver, stryker drive wire (per site reporter): notified representative, they replied "preventative maintenance scheduled to test and aggressively replace wire collets.New tagging system is working well and have replaced another collet since.During preventative maintenance stryker will also discuss sterilization process to ensure that¿s not causing issues.".
 
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Brand Name
STRYKER
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct
san jose CA 95138
MDR Report Key12452366
MDR Text Key270874353
Report Number12452366
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7203026000
Device Catalogue Number7203026000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2021
Event Location Hospital
Date Report to Manufacturer09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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