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 TPS HANDPIECE CORD; DRIVER, WIRE, AND BONE DRILL, MANUAL
  • 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 TPS HANDPIECE CORD; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5100004000
Device Problem Unintended System Motion (1430)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2014
Event Type  malfunction  
Event Description
It was reported that prior to a procedure, the tps handpiece cord was causing various handpieces to vibrate without user activation.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that prior to a procedure the tps handpiece cord was causing various handpieces to vibrate without user activation.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Two additional tps handpiece cords were added as concomitant products as the three cords have not yet been returned for evaluation, so it is unclear at this time which cord caused the reported event.A follow up report will be filed once the cords have been returned and a quality investigation has been completed.
 
Manufacturer Narrative
The device was not received; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.The device was not received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TPS HANDPIECE CORD
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3602400
MDR Text Key4155894
Report Number0001811755-2014-00317
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100004000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
REMB ELECTRIC WIREDRIVER 6400062000 (1303501373); REMB SAG SAW 6400034000 (1303501543); REMB MICRO DRILL 6400015000 (1301401523); TPS HANDPIECE CORD 5100004000 (UNK); REMB OSC SAW 6400031000 (1303505633); TPS HANDPIECE CORD 5100004000 (UNK); REMB SAG SAW 6400034000 (1302816973); REMB UNIVERSAL DRIVER 6400099000 (304200583); REMB RECIP SAW 6400037000 (1302301303); REMB RECIP SAW 6400037000 (1302301293); REMB OSC SAW 6400031000 (1302910833); REMB MICRO DRILL 6400015000 (1301401533)
-
-