MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CONV RP PS TB TRL SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500995

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

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 total knee replacement.(b)(6): (b)(6) hospital, (b)(6) 2018.The spring on the size 5 attune ps rp insert trial broke during removal of the instrument following a trial reduction.All affected parts were accounted for, and the broken spring was discarded by the scrub nurse.Instrument was no longer needed, so operation continued as normal.No ae to patient.No delay to the procedure.Patient initial (b)(6).

Manufacturer Narrative

Investigation summary the device associated with this report was not returned to depuy synthes in warsaw for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ATTUNE CONV RP PS TB TRL SZ5
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• 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: 7703407
• MDR Text Key: 114466138
• Report Number: 1818910-2018-64818
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295135722
• UDI-Public: 10603295135722
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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