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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE 0 DEG RIGHT CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

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DEPUY IRELAND - 9616671 ATTUNE 0 DEG RIGHT CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2544-00-015
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> the device associated with this report was returned for investigation. Examination of the returned device can confirm the complaint. Depuy syntheses considers the investigation closed at this time. Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary. Examination of the returned device can confirm the reported event. Visual examination can see in the groove of the saw capture is deformed, the deformed condition occurred by cutting into by a saw blade. 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 during a routine inspection of some attune consignment instrumentation trays, by sterile processing department personnel, it was discovered that three of the instruments were damaged. Two attune femoral impactor were cracked and the saw capture of a tibial cutting guide had been cut into by a saw blade. Both cracks extended from the central portion to distal portion of the two impactors. The cut in the tibial cutting guide in located in the lateral edge of saw capture. Replacement instruments are needed to complete the consignment trays.
 
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Brand NameATTUNE 0 DEG RIGHT CUT BLOCK
Type of DeviceATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14208577
MDR Text Key290089952
Report Number1818910-2022-07552
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2544-00-015
Device Catalogue Number254400015
Device Lot NumberPG225487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2013
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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