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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7208000000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Abrasion (1689)
Event Date 02/02/2017
Event Type  Injury  
Event Description
The customer reported that during a surgical procedure there was excessive oscillating of the saw that led to a rattling loose of the battery cover.This caused minor damage to the patellar tendon; however, the patellar tendon was repaired and the customer reported that lasting consequences to the patient as a result of this event are not likely.
 
Manufacturer Narrative
Supplemental submitted to document device evaluation results.
 
Event Description
The customer reported that during a surgical procedure there was excessive oscillating of the saw that led to a rattling loose of the battery cover.This caused minor damage to the patellar tendon; however, the patellar tendon was repaired and the customer reported that lasting consequences to the patient as a result of this event are not likely.
 
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Brand Name
SYSTEM 7 SAGITTAL SAW
Type of Device
INSTRUMENT, 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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6358598
MDR Text Key68348211
Report Number0001811755-2017-00672
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7208000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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