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

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; TAP, BONE

  • 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
 

WARSAW ORTHOPEDICS MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; TAP, BONE Back to Search Results
Catalog Number 836-018
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2014
Event Type  malfunction  
Event Description
It was reported that the patient underwent a posterior spinal surgical procedure.It was reported that the shaft of the tap broke during use.The broken portion was removed.No patient complications were reported.
 
Manufacturer Narrative
(b)(4): the device has been returned to the manufacturer for evaluation.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
 
Manufacturer Narrative
Additional info: visually and dimensionally confirmed the instrument is broken at the base of the radius near the 70 mark.No surface defect identified that could contribute to crack propagation.Dimensional inspection of the relevant dimensions, as well as the instrument hardness were inspected and found to be within print specification.Microscopic examination of the fracture surface finds a fairly brittle fracture with no indication of torsion or fatigue, and river lines suggesting the direction of propagation.The location and fractographic evidence of the fracture surface, in conjunction with verification of conformance to the relevant dimensional and material specifications suggest failure due to bend stress overload.The above observations are consistent with bend stress overload.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
Type of Device
TAP, BONE
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3690137
MDR Text Key4298172
Report Number1030489-2014-01901
Device Sequence Number1
Product Code HWX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,company representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/19/2014
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 Number836-018
Device Lot NumberNG03K010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/23/2014
Initial Date FDA Received03/20/2014
Supplement Dates Manufacturer ReceivedNot provided
04/23/2014
Supplement Dates FDA Received05/15/2014
09/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-