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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT; HIP INSTRUMENTS : HANDLES
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DEPUY ORTHOPAEDICS INC US SUMMIT; HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 257000000
Medical Device Problem Codes Device-Device Incompatibility (2919); Unintended Movement (3026)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/15/2026
Type of Reportable Event Malfunction
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Brand Name
SUMMIT
Common Device Name
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
elba bello
700 orthopaedic dr.
warsaw, IN 46581
9083863534
MDR Report Key25765288
Report Number1818910-2026-11693
Device Sequence Number15927574
Product Code HTQ
UDI-Device Identifier10603295142843
UDI-Public(01)10603295142843(10)KA0606
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
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 Number257000000
Device Lot NumberKA0606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2026
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/08/2026
Initial Report FDA Received Date07/09/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured06/15/2006
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 SexMale
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