MAUDE Adverse Event Report: DEPUY IRELAND 961610 ATUN REV RP INSRT TRL SZ7 6MM; TIBIAL TRIALS

Catalog Number 251710706

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 05/04/2018

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

It was reported that attune knee revision rp insert trial sz 7 6mm did not fit in trial femur.Manufacturing error.A replacement trial was ordered and put our set, and works well.Might be a problem with a specific lot.2517-10-706 lot az887033.Surgical delay for 5 minutes.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary evaluation and measurement of the returned device was unable to confirm the reported event.The returned device met print specification.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: ATUN REV RP INSRT TRL SZ7 6MM
• Type of Device: TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7562251
• MDR Text Key: 109889658
• Report Number: 1818910-2018-61165
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295477051
• UDI-Public: 10603295477051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 251710706
• Device Lot Number: AZ887033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• 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