MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP PS ARTIC SURF SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500544

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

It was reported that the poly trials are chipped or broken.

Manufacturer Narrative

Product complaint # : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP PS ARTIC SURF SZ4
• 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 dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8235327
• MDR Text Key: 132784765
• Report Number: 1818910-2019-80424
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295132844
• UDI-Public: 10603295132844
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500544
• Device Lot Number: MVMCCP330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 79 YR