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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE RP TIBIAL IMPACTOR; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. ATTUNE RP TIBIAL IMPACTOR; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254401004
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.
 
Event Description
The attune rp tibia impactor broke while implanting the tibia.
 
Manufacturer Narrative
(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Manufacturer Narrative
(b)(4).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
Conclusion and justification status: the complaint states the attune rp tibia impactor broke while implanting the tibia.The investigation confirmed that the impactor had cracked expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune rp tibial 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.This device is from an 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 justified conclusion; it will be entered into the complaint database and monitored through trend analysis.Depuy still considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
Update mar 10, 2016 - evaluation of the returned product found the instrument to be cracked and not broken as originally stated on the der.The instrument was reported in error.The crack is not a reportable event.
 
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Brand Name
ATTUNE RP TIBIAL IMPACTOR
Type of Device
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key5459746
MDR Text Key38971160
Report Number1818910-2016-14010
Device Sequence Number1
Product Code HWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/23/2016
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 Number254401004
Device Lot NumberAU3967674
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/23/2016
Initial Date FDA Received02/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received02/26/2016
03/04/2016
03/31/2016
10/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2014
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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