MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV FEM BOX TRL SZ 4 L; FEMORAL TRIALS

Catalog Number 250440124

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint sample consisted of (1) 250440124 attune rev fem box trl sz 4 l.Examination of the returned device confirms that the device is unable to be disassembled.The attune rev fem stem trial bolt is deformed and stripped therefore the bolt is unable to be removed.Due to the inability to remove the bolt, the attune rev fem box trl sz 4 l and the attune rev boss adaptor trial are unable to be disassembled.A worldwide complaint database search was performed for this product code, and no other reports have been identified.This appears to be an isolated incident.The root cause could not be determined based on the inability to disassemble the device.Based on the root cause being undetermined, no corrective action is is necessary.Complaints will be monitored through sep-14.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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 damaged during saw bones workshop training.

• Brand Name: ATTUNE REV FEM BOX TRL SZ 4 L
• Type of Device: FEMORAL 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 ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8480280
• MDR Text Key: 140919868
• Report Number: 1818910-2019-89649
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295442554
• UDI-Public: 10603295442554
• 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: 04/02/2019

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 Catalogue Number: 250440124
• Device Lot Number: PG277022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/03/2019
• Date Device Manufactured: 07/09/2018
• 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