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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 P.F.C.* PRESS-FIT ROD WRENCH; KNEE INSTRUMENT : WRENCHES

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DEPUY ORTHOPAEDICS, INC. 1818910 P.F.C.* PRESS-FIT ROD WRENCH; KNEE INSTRUMENT : WRENCHES Back to Search Results
Catalog Number 865189
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
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 handle is extremely difficult to turn.Binding up inside and slow moving.Found in post cleaning inspection.
 
Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : examination of the returned device confirmed the reported bent condition.Depuy considers the investigation closed at this time.Should the 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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Type of Device
KNEE INSTRUMENT : WRENCHES
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 Key7514583
MDR Text Key108269749
Report Number1818910-2018-59653
Device Sequence Number1
Product Code HXC
UDI-Device Identifier10603295216759
UDI-Public10603295216759
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 04/19/2018
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 Number865189
Device Lot NumberTBKLB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/19/2018
Initial Date FDA Received05/15/2018
Supplement Dates Manufacturer Received05/17/2018
Supplement Dates FDA Received05/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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