• 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 IMPACTION 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 IMPACTION HANDLE INSTRUMENT Back to Search Results
Catalog Number 6541-4-810
Device Problem Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 05/08/2015
Event Type  Malfunction  
Event Description

The handle melted after sterilization. Spare product was shipped to the hospital before the medical procedure.

 
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Manufacturer Narrative

An event regarding santoprene handle degradation was reported. The event was confirmed. Method & results: -device evaluation and results: visual analysis confirmed the reported event. The handle was returned degraded. -medical records received and evaluation: not performed because patient factors did not contribute to the reported event. -device history review indicated all devices accepted into stock met specification. -complaint history review indicated there have been other events associate with the reported lot. Conclusions: capa was initiated on 20-oct-2010 because a series of complaints were received for triathlon instrumentation where green santoprene over-mold handles have been reported to be degrading, becoming sticky and unstable. This event was determined to be under the scope of capa. Chemical and cytotoxicity tests showed the degraded santoprene is non-toxic. The ability to clean and sterilize the degraded instruments has not been compromised.

 
Event Description

The handle melted after sterilization. Spare product was shipped to the hospital before the medical procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIMPACTION HANDLE
Type of DeviceINSTRUMENT
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4814838
MDR Text Key17696130
Report Number0002249697-2015-01792
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-4-810
Device LOT NumberN3E30
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/18/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/03/2015 Patient Sequence Number: 1
-
-