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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EXCEL CALCAR MILL LARGE; HIP INSTRUMENTS : CUTTING INSTRUMENTS
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DEPUY ORTHOPAEDICS INC US EXCEL CALCAR MILL LARGE; HIP INSTRUMENTS : CUTTING INSTRUMENTS Back to Search Results
Catalog Number 200149000
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)
Patient Problem Not Applicable (3189)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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 tops of calcar planer loosened and device is stripped.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: examination of the returned instrument could not confirm 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.Territory 202 reported that the tops of calcar planer loosened and instrument is stripped.Examination of the returned instrument could not confirm the reported observation; instrument did not appear to be stripped and assembled/disassembled with the returned mating parts.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient code: no code available (3191) used to capture device slipped.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: product complaint # (b)(4).Investigation summary: examination of the returned instrument could not confirm 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.Device history lot: null.Device history batch: null.Device history review: null.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
EXCEL CALCAR MILL LARGE
Type of Device
HIP INSTRUMENTS : CUTTING INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9152186
MDR Text Key186576518
Report Number1818910-2019-107571
Device Sequence Number1
Product Code LYS
UDI-Device Identifier10603295080022
UDI-Public10603295080022
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 09/12/2019
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
Device Operator Health Professional
Device Catalogue Number200149000
Device Lot NumberHW85387
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2019
Initial Date Manufacturer Received 09/12/2019
Initial Date FDA Received10/03/2019
Supplement Dates Manufacturer Received11/08/2019
12/24/2019
Supplement Dates FDA Received11/11/2019
12/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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