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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE FEMORAL IMPACTOR KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. ATTUNE FEMORAL IMPACTOR KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254401006
Event Date 05/26/2015
Event Type  Malfunction  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

The device associated with this report was not returned. The initial report stated the device would not be returned for evaluation. Expert opinion indicates that the failures are associated with environmental stress cracking (esc). The attune femoral impactor has been annealed to reduce residual stresses. Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable. The annealed product was released on (b)(6) 2014. This device is from an un-annealed batch. A field safety notice was issued in nov 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor¿s to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure. It should be noted that capa-(b)(4) has been initiated and can be referenced for further details. The complaint shall be closed with a unjustified conclusion; it will be entered into the complaint database and monitored through trend analysis. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Manufacturer Narrative

The device associated with this report was not returned. The initial report stated the device would not be returned for evaluation. Expert opinion indicates that the failures are associated with environmental stress cracking (esc). The attune femoral impactor has been annealed to reduce residual stresses. Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable. The annealed product was released on 30-jul-2014. This device is from an un-annealed batch. A field safety notice was issued in nov 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor¿s to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure. It should be noted that (b)(4) has been initiated and can be referenced for further details. The complaint shall be closed with a unjustified conclusion; it will be entered into the complaint database and monitored through trend analysis. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Event Description

The attune femoral impactor broke during surgery.

 
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
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Brand NameATTUNE FEMORAL IMPACTOR
Type of DeviceKNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
steve dowell
700 orthopaedic drive
warsaw , IN 46581
5743714918
MDR Report Key4805655
Report Number1818910-2015-22284
Device Sequence Number1
Product CodeLXH
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 05/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254401006
Device LOT NumberAU3357853
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/02/2013
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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