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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 56MM TRIAL INSTRUMENT

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DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 56MM TRIAL INSTRUMENT Back to Search Results
Catalog Number 244000556
Device Problem Insufficient Information
Event Date 11/24/2017
Event Type  Malfunction  
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

On (b)(6) 2017, at the time when the stock point area was delivering the products to use in a surgery, the material was rejected by the hospital due to points of rusting in the materials, as shown in the pictures. The products are segregated to no use and will be shipped to analysis. The products were not used. Products involved and quantity: 244000536 so2017329 fresa acetabular pinnacle tam 36mm 1. 244000537 so2014053 fresa acetabular pinnacle tam 37mm 1. 244000538 so2017481 fresa acetabular pinnacle tam 38mm 1. 244000539 so2017991 fresa acetabular pinnacle tam 39mm 1. 244000540 so2018302 fresa acetabular pinnacle tam 40mm 1. 244000541 so2013671 fresa acetabular pinnacle tam 41mm 1. 244000542 so2011373 fresa acetabular pinnacle tam 42mm 1. 244000543 so2014494 fresa acetabular pinnacle tam 43mm 1. 244000544 so2017951 fresa acetabular pinnacle tam 44mm 1. 244000545 so2017602 fresa acetabular pinnacle tam 45mm 1. 244000546 so2011857 fresa acetabular pinnacle tam 46mm 1. 244000547 so2014093 fresa acetabular pinnacle tam 47mm 1. 244000548 so2013337 fresa acetabular pinnacle tam 48mm 1. 244000549 so2015991 fresa acetabular pinnacle tam 49mm 1. 244000550 so2011877 fresa acetabular pinnacle tam 50mm 1. 244000551 so20154000 fresa acetabular pinnacle tam 51mm 1. 244000552 so2013555 fresa acetabular pinnacle tam 52mm 1. 244000553 so2018039 fresa acetabular pinnacle tam 53mm 1. 244000554 so2017456 fresa acetabular pinnacle tam 54mm 1. 244000555 so2015412 fresa acetabular pinnacle tam 55mm 1. 244000556 so2017088 fresa acetabular pinnacle tam 56mm 1. 244000557 so2013495 fresa acetabular pinnacle tam 57mm 1. 244000558 so2016047 fresa acetabular pinnacle tam 58mm 1. 244000559 so2015155 fresa acetabular pinnacle tam 59mm 1. 244000560 so2001627 fresa acetabular pinnacle tam 60mm 1. 244000561 so2001627 fresa acetabular pinnacle tam 61mm 1. 244000562 so2007831 fresa acetabular pinnacle tam 62mm 1. 244000563 so2017975 fresa acetabular pinnacle tam 63mm 1. 244000564 so2012617 fresa acetabular pinnacle tam 64mm 1. 244000565 so2025866 fresa acetabular pinnacle tam 65mm 1. 244000566 so2025010 fresa acetabular pinnacle tam 66mm 1. 244000567 so2023295 fresa acetabular pinnacle tam 67mm 1. 244000568 e4lbw4000 fresa acetabular pinnacle tam 68mm 1. Complaint is being registered late, since the (b)(4) alert date is (b)(4) 2017 and the (b)(4) stock point sent it to us on 29/11/2017.

 
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Brand NameQUICKSET ACE GRATER HEAD 56MM
Type of DeviceTRIAL INSTRUMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46582
MDR Report Key7126629
Report Number1818910-2017-51968
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000556
Device LOT NumberSO2017088
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/26/2014
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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