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 GMBH CONNECTING BOLT OMEGA; ORTHOPEDIC MANUAL SURGICAL 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 GMBH CONNECTING BOLT OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 704004
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2014
Event Type  malfunction  
Event Description
It was reported that lag screw was inserted in the femoral head after traditional measuring techniques.Lag screw wrench and internal connection rod disconnected from the lag screw.Residents were asked to reinsert the teeth of the wrench under floro then rethread the internal connection rod.They felt that they had done so, but could not advance or remove lag screw and felt that the teeth and internal threads in the lag screw had stripped and we needed to explore other options to advance the screw to desired its desired position.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Manufacturer Narrative
The reported incident that connecting bolt omega was alleged of issue s-43 (assembling issue) could not be confirmed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection showed; some damages on the tread turns are clearly evident.Tests with a new lag screw showed though, that the bolt could still be screwed in and out without any problem.These damages on the tread may indicate that the inner thread of the used lag screw may have been damaged during insertion (implanted).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
 
Event Description
It was reported that lag screw was inserted in the femoral head after traditional measuring techniques.Lag screw wrench and internal connection rod disconnected from the lag screw.Residents were asked to reinsert the teeth of the wrench under floro then rethread the internal connection rod.They felt that they had done so, but could not advance or remove lag screw and felt that the teeth and internal threads in the lag screw had stripped and we needed to explore other options to advance the screw to desired its desired position.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONNECTING BOLT OMEGA
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3738153
MDR Text Key4272458
Report Number0008031020-2014-00156
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/16/2014
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 Catalogue Number704004
Device Lot NumberR26129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/16/2014
Initial Date FDA Received04/10/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2013
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 Age62 YR
-
-