• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT ADVANCED LOW PROFILE BROACH HANDLE; INSTRUMENT

  • 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 ORTHOPAEDICS-MAHWAH SECUR-FIT ADVANCED LOW PROFILE BROACH HANDLE; INSTRUMENT Back to Search Results
Catalog Number 1601-3100
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2015
Event Type  malfunction  
Event Description
Broach handle broke during a primary hip surgery.No consequence to patient.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
The reported event was confirmed.Examination by material analysis team stated that the device fractured due to overload.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
 
Event Description
Broach handle broke during a primary hip surgery.No consequence to patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SECUR-FIT ADVANCED LOW PROFILE BROACH HANDLE
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4643471
MDR Text Key5597117
Report Number0002249697-2015-00997
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,health professional,oth
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1601-3100
Device Lot NumberB7CAF
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/05/2015
Initial Date FDA Received03/31/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/04/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/27/2012
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) Other;
-
-