MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE FB TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Catalog Number 254401003

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Attune tkjr; the surgeon, (b)(6) hospital (b)(6) 2018.The attune fb tibial impactor fractured while being correctly utilised to impact the definitive attune fb tibial tray implant.Immediately replaced with the femoral impactor due to time critical cementing.No adverse outcome for the patient.Wound inspected for plastic fragments and washed out.Patient outcome post surgery: procedure continued as expected.Patient wound inspected and washed out in case of plastic fragments from fractured impactor.Patient fine.Male patient id: (b)(6), aged (b)(6) years, dob: (b)(6).Unknown jrn: attune fb tibial impactor = discarded.

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FB TIBIAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7629982
• MDR Text Key: 112051332
• Report Number: 1818910-2018-62964
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130192
• UDI-Public: 10603295130192
• Combination Product (y/n): N
• 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
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• 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
• Patient Age: 49 YR