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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ7 16MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS
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DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ7 16MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Model Number 2545-00-943
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported by cssd orthotech there were broken instruments.The date of event is unknown for the breakage.It isn¿t broken into two or more pieces.The extent of the damage is unknown at this stage.
 
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Brand Name
ATTUNE CONV SHIM SZ7 16MM
Common Device Name
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12089831
Report Number1818910-2021-13909
Device Sequence Number20080513
Product Code HWT
UDI-Device Identifier10603295135203
UDI-Public10603295135203
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/17/2021
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
Operator of Device Health Professional
Device Model Number2545-00-943
Device Catalogue Number254500943
Device Lot NumberBFA0QCJ
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/17/2021
Initial Report FDA Received Date06/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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