MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CONV RP PS TB TRL SZ9; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500999

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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

It was reported that the instruments were broken.Didn't impact any case.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported event.The larger balseal is damaged and still intact.Hhe (health hazard evaluation)/qrb (quality review board) (b)(4) recommended a device correction which was initiated on (b)(4) 2015.(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.(b)(4) will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor per post market surveillance (b)(4).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 SZ9
• 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: 7674102
• MDR Text Key: 113555956
• Report Number: 1818910-2018-64133
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295135760
• UDI-Public: 10603295135760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500999
• Device Lot Number: BFA0YFQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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