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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE LTL CEM TIBIAL DRILL; DRILLS

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DEPUY IRELAND - 9616671 ATTUNE LTL CEM TIBIAL DRILL; DRILLS Back to Search Results
Model Number 2545-00-165
Device Problems Break (1069); Contamination /Decontamination Problem (2895)
Patient Problem Not Applicable (3189)
Event Date 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes 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.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.
 
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 after attune rp tibial prep was completed the surgeon noted two small green colored foreign objects in the wound.One piece about 1/2 inch long and about 2-3 mm wide, the second piece shorter but about same width.It took a minute ot two ro figure out the foreign bodies were from the green color band of ltl cemented tibial drill, part# d254500165.The wound was doubled recheck and the case proceeded without further incidence.A surgical delay of 2-3 minutes.
 
Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE LTL CEM TIBIAL DRILL
Type of Device
DRILLS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9525773
MDR Text Key176518692
Report Number1818910-2019-124770
Device Sequence Number1
Product Code HTW
UDI-Device Identifier10603295445647
UDI-Public10603295445647
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,Followup
Report Date 12/06/2019
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 Model Number2545-00-165
Device Catalogue Number254500165
Device Lot NumberNG76827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer Received12/20/2019
01/27/2020
Supplement Dates FDA Received01/14/2020
01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
Patient Weight109
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