MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE IMPACTION HANDLE; ATTUNE INSTRUMENTS : HANDLES

Catalog Number 254401017

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

(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

Attune impactor handle, cat no.(b)(4) ,lot no.Nw152969 broke during tibia preparation and attune artic surface ring(cat no.-(b)94),lot no.Mvmbsy780) came out while removing insert during attune case at medanta the medicity causing a surgery delay of 5 mins to find broken parts, this has happened the fourth time.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary conclusion and justification status: the complaint states attune impactor handle, cat no.(b)(4), lot no.Nw152969 broke during tibia preparation.The investigation confirmed that the lever had broken as reported.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 with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.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.

• Brand Name: ATTUNE IMPACTION HANDLE
• Type of Device: ATTUNE INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19830 ; 6103142063
• MDR Report Key: 7171419
• MDR Text Key: 96602625
• Report Number: 1818910-2018-50478
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295423324
• UDI-Public: 10603295423324
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• 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: NW152969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1