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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION OMEGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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STRYKER CORPORATION OMEGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Model Number 3910500471
Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 11/10/2020
Event Type  malfunction  
Event Description
During a rotator cuff repair surgery, a stryker omega 4.75mm peek knotless anchor system brought in by the company representative was being used.The all-peek self-punching knotless anchor with screw-in fixation is a 4.75mm plastic tip.As the anchor system was being placed on top of the aperture to the eyelet, the surgeon may have hit the acromion causing the device to slid anteriorly into the deltoid muscle.When the doctor pulled the device out the anchor, the inserter was pulled off as well.After an ultrasound, an x-ray and an additional laparoscopic procedure, they were unable to locate the anchor and the patient was closed and taken to recovery.
 
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Brand Name
OMEGA
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct
san jose CA 95138
MDR Report Key10859981
MDR Text Key216877974
Report Number10859981
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/11/2020
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 Model Number3910500471
Device Catalogue Number3910-500-471
Device Lot Number20055AG2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2020
Event Location Hospital
Date Report to Manufacturer11/18/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age22265 DA
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