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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BROACH SZ6 HIP INSTRUMENTS : BROACHES

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DEPUY ORTHOPAEDICS INC US SUMMIT BROACH SZ6 HIP INSTRUMENTS : BROACHES Back to Search Results
Model Number 2570-00-120
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 06/23/2020
Event Type  Malfunction  
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 Description

It was reported that the stem on size 6 summit broach was bent while trying to extract the broach from the patient. It is bent to the point that it cannot attach to the broach handle appropriately. The broach has been used in over 200 surgeries. The broach was hard to extract so the time of the surgery was extended by 30 minutes while the surgeon tried to extract the broach.

 
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Brand NameSUMMIT BROACH SZ6
Type of DeviceHIP INSTRUMENTS : BROACHES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10240017
MDR Text Key197812276
Report Number1818910-2020-15139
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 06/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2570-00-120
Device Catalogue Number257000120
Device LOT NumberA0605
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/15/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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