MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE ALIGNMENT HANDLE; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number 254401011

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

(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

Upon routine inspection in spd, it was noted that two attune items have been broken in prior surgeries.These events were not reported during surgery, so no adverse effects were reported.The attune articulating shim has cracks on both sides, the ballseals are still in tact.As for the attune tibial handle, the red spring loaded button has broken off and can no longer be used.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: lot, concomitant medical products and device manufacture date.Corrected: device evaluated by mfr.Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE ALIGNMENT HANDLE
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8302638
• MDR Text Key: 134923209
• Report Number: 1818910-2019-83163
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295130260
• UDI-Public: 10603295130260
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401011
• Device Lot Number: PG1011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1