Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 7208000000
Device Problems Fitting Problem (2183); Device Handling Problem (3265)
Patient Problems Abrasion (1689); Laceration(s) (1946)
Event Date 05/07/2020
Event Type  Injury  
Event Description
It was reported that the device was cutting erratically during a procedure and hit the patella tendon of the patient.The patient required the addition of two stitches to repair the patella tendon.The device was removed from case and finished with a different saw.The patient didn't require any additional medical intervention and did not have any additional complications due to the event.The procedure was completed successfully and no additional medical intervention was necessary.
 
Event Description
It was reported that the device was cutting erratically during a procedure and hit the patella tendon of the patient.The patient required the addition of two stitches to repair the patella tendon.The device was removed from case and finished with a different saw.The patient didn't require any additional medical intervention and did not have any additional complications due to the event.The procedure was completed successfully and no additional medical intervention was necessary.
 
Manufacturer Narrative
Inputted data into d9.Inputted h6 method, results and conclusion codes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key10116097
MDR Text Key193718923
Report Number0001811755-2020-01379
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07613252251033
UDI-Public07613252251033
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
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7208000000
Device Catalogue Number7208000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Date Manufacturer Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-