MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE TIBIAL TRIAL EXTRACTOR; ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2545-00-138

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.The noted damage is consistent with material overload through the use of excessive force and the investigation did not establish a need for corrective action.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Examination of the returned device confirmed the reported breakage.The tip of one of the two prongs was fractured, and the broken fragment was not returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The instrument was reported for unknown reason.

Manufacturer Narrative

Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.The previous reported device code no apparent adverse event is being retracted since it was incorrectly submitted in the initial medwatch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE TIBIAL TRIAL EXTRACTOR
• Type of Device: ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10379556
• MDR Text Key: 202041046
• Report Number: 1818910-2020-17755
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295131021
• UDI-Public: 10603295131021
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-138
• Device Catalogue Number: 254500138
• Device Lot Number: BFA0NRY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR