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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  SROM TRI BAND CONE REAMER 19 HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910  SROM TRI BAND CONE REAMER 19 HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257602019
Device Problems Material Discolored (1170); Naturally Worn (2988); Optical Discoloration (2999)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
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

Excessive wear and lack of sharpness of some s-rom loaner set especially when soiled with blood.

 
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.

 
Manufacturer Narrative

Product complaint # : (b)(4). 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, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

Product complaint # : (b)(4). 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, a follow-up medwatch will be filed as appropriate.

 
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Brand NameSROM TRI BAND CONE REAMER 19
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
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8196845
MDR Text Key131480593
Report Number1818910-2018-79125
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number257602019
Device LOT NumberMT0108
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/18/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/15/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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