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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS BROACH SZ 7; HIP INSTRUMENTS : BROACHES
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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS BROACH SZ 7; HIP INSTRUMENTS : BROACHES Back to Search Results
Catalog Number 201203070
Medical Device Problem Codes Device-Device Incompatibility (2919); Scratched Material (3020)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/25/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.
 
Event or Problem Description
It was reported that the tri lock broach sz.7 would not seat onto the broach handle.Upon inspection, neck that attaches to broach is scarred and would not allow seating.No surgical delay.
 
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Brand Name
TRI-LOCK BPS BROACH SZ 7
Common Device Name
HIP INSTRUMENTS : BROACHES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7698252
Report Number1818910-2018-64686
Device Sequence Number16369908
Product Code HTQ
UDI-Device Identifier10603295082125
UDI-Public10603295082125
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
NI
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/25/2018
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 Number201203070
Device Lot NumberPG238475
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/25/2018
Initial Report FDA Received Date07/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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