MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE IMPACTION HANDLE; KNEE INSTRUMENT/TRIAL

Catalog Number 254401017

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Conclusion and justification status: the complaint states procedure: total knee replacement.During impaction of the definitive tibial tray, the attune impaction handle locking mechanism broke.The operation was completed using the 2nd handle included in the attune tibial preparation and impaction tray.One minute delay in procedure.No adverse event to patient the investigation could not confirm the complaint as no device was returned.It should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure the complaint shall be closed to capa; it will be entered into the complaint database and monitored through trend analysis.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

Event Description

The attune impaction handle locking mechanism broke.The damage occurred whilst impacting the definitive tibial tray into the patient.The impactor handle broke into three pieces at the locking mechanism which allows it to connect to other instruments in the set.All three broken pieces were retrieved from the patient.

Manufacturer Narrative

Conclusion and justification status: the complaint states procedure: total knee replacement.During impaction of the definitive tibial tray, the attune impaction handle locking mechanism broke.The operation was completed using the 2nd handle included in the attune tibial preparation and impaction tray.One minute delay in procedure.No adverse event to patient.The investigation could not confirm the complaint as no device was returned.It should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.The complaint shall be closed to capa; 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

Udi# (b)(4).The investigation has been reopened because the product has been received.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Conclusion and justification status: the complaint states procedure: total knee replacement.During impaction of the definitive tibial tray, the attune impaction handle locking mechanism broke.The operation was completed using the 2nd handle included in the attune tibial preparation and impaction tray.1 minute delay in procedure.No adverse event to patient the investigation could not confirm the complaint as no device was returned.It should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure the complaint shall be closed to capa; it will be entered into the complaint database and monitored through trend analysis.Addendum added 08 dec 2016.The complaint was reopened as the device was returned and confirmed the failure mode as reported.All pieces were returned.The above conclusion remains valid.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

Event Description

The attune impaction handle locking mechanism broke.The damage occurred whilst impacting the definitive tibial tray into the patient.The impactor handle broke into three pieces at the locking mechanism which allows it to connect to other instruments in the set.All three broken pieces were retrieved from the patient.

• Brand Name: ATTUNE IMPACTION HANDLE
• 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 Key: 6081326
• MDR Text Key: 59336405
• Report Number: 1818910-2016-30905
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401017
• Device Lot Number: NW152963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1