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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

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DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Catalog Number 254500505
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2018
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
It was reported that the size 5 fb ps poly trial broke during efforts to removed, would like easier method.
 
Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.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 Name
ATTUNE FB PS ARTIC SURF SZ5
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743725905
MDR Report Key7684894
MDR Text Key113874379
Report Number1818910-2018-64340
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295132455
UDI-Public10603295132455
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/20/2018
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 Number254500505
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2018
Initial Date FDA Received07/13/2018
Supplement Dates Manufacturer Received08/14/2018
Supplement Dates FDA Received08/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age69 YR
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