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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 BROACH HNDL-45 DEG COLLAR ANGL; HIP INSTRUMENTS : HANDLES
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DEPUY ORTHOPAEDICS, INC. 1818910 BROACH HNDL-45 DEG COLLAR ANGL; HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 856696
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/17/2018
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
The broach handle snapped and the impaction plate fell off.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
BROACH HNDL-45 DEG COLLAR ANGL
Common Device Name
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8032431
Report Number1818910-2018-74282
Device Sequence Number1379537
Product Code HTQ
UDI-Device Identifier10603295214465
UDI-Public10603295214465
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/17/2018
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 Number856696
Device Lot NumberA1104
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/17/2018
Supplement Date Received by Manufacturer12/11/2018
Initial Report FDA Received Date11/02/2018
Supplement Report FDA Received Date12/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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