MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIBIAL TRIAL EXTRACTOR; ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2545-00-138

Device Problem Break (1069)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device revealed the extractor was broken.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.

Event Description

The event was reported for unknown reason.

• Brand Name: ATTUNE TIBIAL TRIAL EXTRACTOR
• Type of Device: ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS
• 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 ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 10817152
• MDR Text Key: 215527720
• Report Number: 1818910-2020-24332
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295131021
• UDI-Public: 10603295131021
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2020

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: BFA0NSG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• 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
• Patient Age: 64 YR