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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DISTAL FEM CUT BLOCK; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

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DEPUY IRELAND - 9616671 ATTUNE DISTAL FEM CUT BLOCK; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 254400522
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2024
Event Type  malfunction  
Event Description
It was reported that the pin got stuck in distal femoral cutting block.An alternative tray needed to be opened.Something was catching on pins on pin hole.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "pin got stuck in distal femoral cutting block." the product was not returned to depuy synthes, however photos were provided for review.The photo/x-ray investigation revealed that attune distal fem cut block had jammed/seized.The provided evidence was not sufficient to confirm the allegation of jammed/seized.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the attune distal fem cut block would not contribute to the complained device issue.Based on the investigation findings, cause not established and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE DISTAL FEM CUT BLOCK
Type of Device
ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key19050893
MDR Text Key339483400
Report Number1818910-2024-07655
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295423737
UDI-Public10603295423737
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/05/2024
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 Number254400522
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/05/2024
Supplement Dates Manufacturer Received04/15/2024
04/19/2024
Supplement Dates FDA Received04/16/2024
04/22/2024
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
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