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 ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; 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 UNIVERSAL IMPACTOR/POSTIONER; INSTRUMENT Back to Search Results
Catalog Number 2101-0200
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2015
Event Type  malfunction  
Event Description
The sales rep.Reported on behalf of the customer that during or the surgeon wanted to place the cup, but then noticed that the screw-thread was too long.The or team had to open another net to place the cup.
 
Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
 
Manufacturer Narrative
An event regarding excessive thread length involving a universal acetabular shell impactor was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspections found that the interface between the threaded stud subcomponent and handle bore showed only limited signs of press-fit assembly.In addition, dimensional inspection confirmed that the threaded stud protrusion past the impaction shoulder feature of the handle assembly was not within specification.-medical records received and evaluation: clinician review was not performed as there is no indication that the event was related to patient factors.-device history review: -device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review found no other similar events have been reported for the subject manufacturing lot.Conclusions: the investigation determined that the reported failure has been previously investigated under (b)(4) was opened to further investigate the observed non-conformance.
 
Event Description
The sales rep.Reported on behalf of the customer that during or the surgeon wanted to place the cup, but then noticed that the screw-thread was too long.The or team had to open another net to place the cup.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIVERSAL IMPACTOR/POSTIONER
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4601871
MDR Text Key17294887
Report Number0002249697-2015-00731
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K123604
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2101-0200
Device Lot NumberSMM8W07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2014
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;
-
-