• 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 MCREYNOLDS IMPACTOR ADAPTER; 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 MCREYNOLDS IMPACTOR ADAPTER; INSTRUMENT Back to Search Results
Catalog Number 6260-4-090
Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2015
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
Extractor tip broke off inside stem.
 
Manufacturer Narrative
An event regarding fracture involving a mcreynolds adapter was reported.The event was confirmed.Method & results: -device evaluation and results: thread damage was observed on the adapter tip as well as on the edges of the fractured portion stuck in the stem.-medical records received and evaluation: not performed as there is no indication the event is related to patient factors.-device history review: review of the device history records indicates all devices accepted into final stock met specifications.-complaint history review: there have been 2 other events for this lot.Conclusions: the investigation concluded that the device fractured in overload.Damage to the threads was observed.The exact origin of the damage could not be determined.It is possible the thread damage was hindering the smooth threading of the adapter in the distal stem.This could have led to seizing of the adapter in the distal stem and subsequent fracture of the device.
 
Event Description
Extractor tip broke off inside stem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MCREYNOLDS IMPACTOR ADAPTER
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5062454
MDR Text Key25818857
Report Number0002249697-2015-02928
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 health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/27/2016
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 Expiration Date09/15/2015
Device Catalogue Number6260-4-090
Device Lot NumberTACJ50A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/11/2015
Initial Date FDA Received09/08/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2008
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;
Patient Age81 YR
-
-