MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DISTAL FEMORAL JIG; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Model Number 2544-00-520

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

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

It was reported that the doctor was trying to use a drill in thru cutting jig and the metal bushing popped out.Both jig and metal bushing retrieved from patient.Another jig was used.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device revealed the metal bushing was dislodged and missing.Root cause and corrective action are documented in the capa system.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.

• Brand Name: ATTUNE DISTAL FEMORAL JIG
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10860528
• MDR Text Key: 216864421
• Report Number: 1818910-2020-24741
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295434030
• UDI-Public: 10603295434030
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-00-520
• Device Catalogue Number: 254400520
• Device Lot Number: ABC22844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR