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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN OTHER PRODUCTS

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN OTHER PRODUCTS Back to Search Results
Catalog Number UNK KNEE INSTRUMENT
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
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
It was reported that the 5mm aug broke while removing it. It was thrown away by spd. No surgical delay and all pieces were retrieved.
 
Manufacturer Narrative
Product complaint (b)(4). Investigation summary no device was received for examination, therefore the reported event could not be confirmed. Depuy considers the investigation closed. 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 NameUNKNOWN OTHER PRODUCTS
Type of DeviceOTHER PRODUCTS
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
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key7555600
MDR Text Key109704692
Report Number1818910-2018-60920
Device Sequence Number1
Product Code HTJ
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 05/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK KNEE INSTRUMENT
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 Received11/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/30/2018 Patient Sequence Number: 1
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