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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER TRAUMA KIEL GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 23510030
Device Problems Disconnection (1171); Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Surgeon was using the t2 alpha guide wire gripper, whilst using it a small screw fell out.There was a slight delay of 5 minutes in the procedure as the staff fetched another guide wire handle.Stryker rep reported that there was no impact to the patient.
 
Manufacturer Narrative
The reported event could be confirmed.Based on investigation an exact root cause could not be determined but nothing was reported during pre-operative check, which is required per ifu.In case of any material integrity issues it would have been noticed during inspection steps performed.The device inspection revealed the following: we received a guide wire handle imn instruments for evaluation.Detailed visual inspection revealed a loosened pin, which shows traces of pushing out and one missing pin.Due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection of the returned pin, handle and clamping barrel revealed the required measurements within specification.Although the loosened pin could be confirmed, required measurements were within specification.Review of historical data revealed the current case as a single case.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.
 
Event Description
Surgeon was using the t2 alpha guide wire gripper, whilst using it a small screw fell out.There was a slight delay of 5 minutes in the procedure as the staff fetched another guide wire handle.Stryker rep reported that there was no impact to the patient.
 
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Brand Name
GUIDE WIRE HANDLE IMN INSTRUMENTS
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8732805
MDR Text Key149201552
Report Number0009610622-2019-00519
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07613327361674
UDI-Public07613327361674
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number23510030
Device Lot NumberKME912621
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Date Manufacturer Received08/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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