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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 7206000000
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 12/31/2019
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 2 previously reported events was included under mfr report # 0001811755-2020-00245 but should be included under this report. Product return status: 2 devices were received. Event confirmation status: 1 reported event was confirmed. 1 reported event was not confirmed. Evaluation results: 2 devices were found to be affected by a corroded trigger assembly.
 
Event Description
This report summarizes 2 malfunction events in which the device ran without user activation. 2 events had no patient involvement; no patient impact.
 
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Brand NameSYSTEM 7 RECIPROCATING SAW
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key10011416
MDR Text Key189440472
Report Number0001811755-2020-01240
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7206000000
Device Catalogue Number7206000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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