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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SUMMIT CALCAR PLANER-SMALL HIP INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. SUMMIT CALCAR PLANER-SMALL HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 257004100
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Information (3190)
Event Date 05/24/2017
Event Type  malfunction  
Manufacturer Narrative
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.
 
Manufacturer Narrative
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 while cleaning up from case, it was discovered that the calcar planer was missing the internal cylinder from the cutting end of the planer. It was stated that the piece was found and returned to the office.
 
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Brand NameSUMMIT CALCAR PLANER-SMALL
Type of DeviceHIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6737137
MDR Text Key104470510
Report Number1818910-2017-21666
Device Sequence Number1
Product Code KWY
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
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number257004100
Device Lot NumberHT0608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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