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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 60MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES
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DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 60MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES Back to Search Results
Catalog Number 221890060
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Total hip replacement: buderim private hospital tab has broken off pinnacle 60mm ab gripper.Photo uploaded to unity.
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.The provided photographs confirmed the reported observation.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
PINNACLE 60MM GRIPPER
Common Device Name
HIP INSTRUMENTS : INSERTION DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7635091
Report Number1818910-2018-63089
Device Sequence Number16764709
Product Code LXH
UDI-Device Identifier10603295102328
UDI-Public10603295102328
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/04/2018
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 Number221890060
Device Lot NumberA0107
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/04/2018
Supplement Date Received by Manufacturer11/27/2018
Initial Report FDA Received Date06/25/2018
Supplement Report FDA Received Date11/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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