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 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE
  • 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 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 2030-6525-1
Device Problems Break (1069); Fracture (1260); Device Slipped (1584); Material Integrity Problem (2978)
Patient Problems Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 12/30/2013
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.
 
Event Description
Upon starting surgery we discovered a loose acetabular tritanium cup with a broken screw.We also noticed slight metal transfer to the biolox head.Unexplainably as there was no debris in the poly.Furthermore, there was metal transfer around the v-40 taper junction.The accolade femoral component was fixed.As per sales rep, patient was revised due to loosening.
 
Manufacturer Narrative
An event regarding crack/fracture involving an other hip screw was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection of the device pictures noted that the device was fractured and worn.The screw is fractured after the second thread.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.Device history review: the review indicates that the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the device was not returned but the pictures of the alleged device were received.A visual inspection of the device pictures noted that the device was fractured and worn.The screw is fractured after the second thread.A capa trend analysis was conducted for the reported failure mode and concluded fracture may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
 
Event Description
Upon starting surgery we discovered a loose acetabular tritanium cup with a broken screw.We also noticed slight metal transfer to the biolox head.Unexplainably as there was no debris in the poly.Furthermore, there was metal transfer around the v-40 taper junction.The accolade femoral component was fixed.As per sales rep, patient was revised due to loosening.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
6.5 CANCELLOUS BONE SCREW 25MM
Type of Device
SCREW, FIXATION, BONE
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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5988490
MDR Text Key56337200
Report Number0002249697-2016-03087
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894124
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 02/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2018
Device Catalogue Number2030-6525-1
Device Lot NumberMMNY00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight75
-
-