• 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 TIBIAL ALIGNMENT 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 TIBIAL ALIGNMENT HANDLE INSTRUMENT Back to Search Results
Catalog Number 6541-2-807
Device Problems Contamination (1120); Material Disintegration (1177); Melted (1385); Material Integrity Problem (2978); Adhesive (3194)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2015
Event Type  Malfunction  
Event Description

Staff made rep aware that devices "potentially" had adhesive melt under rubber handle. Noticed oil in bottom of tray when it came out of autoclave. No patient outcome was compromised because pan wasn't in operating room. Room and additional trays were available and used.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Visual inspection confirmed the reported event; the handle of the device is discolored and degraded. The damaged device was discovered during inspection; there was no surgical procedure associated with the reported event. This event meets the definition of preventive maintenance; no further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Staff made rep aware that devices "potentially" had adhesive melt under rubber handle. Noticed oil in bottom of tray when it came out of autoclave. No patient outcome was compromised because pan wasn't in o. R. Room and additional trays were available and used.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTIBIAL ALIGNMENT 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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4624413
MDR Text Key5654566
Report Number0002249697-2015-00853
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
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 01/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-2-807
Device LOT NumberN3L13
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2008
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: 03/23/2015 Patient Sequence Number: 1
-
-