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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE EM TIBIAL PROX UPROD; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
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DEPUY IRELAND - 9616671 ATTUNE EM TIBIAL PROX UPROD; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES Back to Search Results
Catalog Number 254400017
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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 numbers are worn off of the tibial jig and the distal femoral jig.The numbers are not legible and the instruments need to be replaced.Nothing is broken nor did anything break during surgery.All information is included.No other information is available.
 
Manufacturer Narrative
Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.
 
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Brand Name
ATTUNE EM TIBIAL PROX UPROD
Type of Device
ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12175068
MDR Text Key261756543
Report Number1818910-2021-15315
Device Sequence Number1
Product Code HWT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254400017
Device Lot NumberPG229017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Date Manufacturer Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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