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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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DEPUY MITEK LLC US EXPRESSEW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 214124
Medical Device Problem Codes Device-Device Incompatibility (2919); Difficult to Open or Close (2921); Unintended Movement (3026)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/27/2026
Type of Reportable Event Malfunction
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Brand Name
EXPRESSEW
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
elba bello
325 paramount drive
raynham, MA 02767
9083863534
MDR Report Key25766207
Report Number1221934-2026-02970
Device Sequence Number18588762
Product Code LXH
UDI-Device Identifier10886705003655
UDI-Public(01)10886705003655(10)6141421050702
Combination Product (Y/N)N
Initial Reporter CountryBE
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,User Facility,Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/09/2026
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 Catalogue Number214124
Device Lot Number6141421050702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2026
Initial Report FDA Received Date07/09/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured05/07/2021
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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