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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH IMPACTOR ASSEMBLY OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER GMBH IMPACTOR ASSEMBLY OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 704001
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/19/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event or Problem Description
The surgeon reported that he was doing a dhs using the one step method.The head of the lag screw stripped, and when impacting the plate the black plastic part of the impactor snapped at the end of the screw thread.A second dhs set was opened and this occurred again, (part number 704001).
 
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Brand Name
IMPACTOR ASSEMBLY OMEGA
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key9838341
Report Number0008031020-2020-00722
Device Sequence Number11422244
Product Code LXH
UDI-Device Identifier04546540113078
UDI-Public04546540113078
Combination Product (Y/N)N
Initial Reporter CountryGB
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/16/2020
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
Operator of Device Health Professional
Device Model Number704001
Device Catalogue Number704001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/19/2020
Initial Report FDA Received Date03/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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