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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 7205000000
Device Problems Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993); Intermittent Loss of Power (4016)
Patient Problems Bone Fracture(s) (1870); Insufficient Information (4580)
Event Date 04/27/2021
Event Type  Injury  
Event Description
It was reported during a procedure that a patient required revision surgery.The revision surgery was successful with no long term impact to the patient.
 
Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
Event Description
It was reported during a procedure that a patient required revision surgery.The revision surgery was successful with no long term impact to the patient.
 
Manufacturer Narrative
Corrected data: b3, b5, section e, h6 device code, component code, results code.
 
Event Description
It was reported that the drill stopped/stalled during a hip replacement procedure on (b)(6) 2021 at spire liverpool hospital.When it re-started, it caught on the bone and jolted it, causing a fracture.After the fracture occurred, the femur required wiring.The patient was then taken over the nhs hospital a week later.Revision surgery to complete the original hip replacement procedure was conducted on (b)(6) 2021 at broadgreen hospital.Once the revision was completed, three days post-op, the patient was weight bearing and pain free.The revision was successful.
 
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Brand Name
SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
colette chung
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key12063593
MDR Text Key258678654
Report Number0001811755-2021-00777
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7205000000
Device Catalogue Number7205000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2016
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; Hospitalization; Other;
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