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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 45MM HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 45MM HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000545
Device Problem Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
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

Event: after the process of pre-washing and sterilized the product (drill) were oxidized. Details of the event: the new products entered yesterday ((b)(6) 2018) to the (b)(6), which were washed and brushed by hand one by one inside and outside, with 10 minutes of submerged. This process was done 3 times yesterday. Today they were steam sterilized and when they came out they had spots of drops. They were submerged again with enzymatic for 10 minutes and when went back, they were brushed one by one and with a sponge and all the spots were removed. After this, they was put in the process of washing and drying machine and finished this cycle , it was identified that those have the small laser letter were oxidized. I detail below the list of code and lot of them, are 25 in total: product information: (b)(4). As the product complaint has several products (ip), we registered 2 complaints ((b)(4)). The complaint (b)(4) involved: (b)(4).

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: the instrument associated with this report was not returned. 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.

 
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Brand NameQUICKSET ACE GRATER HEAD 45MM
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7645154
MDR Text Key112876953
Report Number1818910-2018-63382
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000545
Device LOT NumberSO2025326
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/11/2016
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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