MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PATELLA DRILL CLAMP; ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS

Catalog Number 254501041

Device Problems Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

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

Nurses reported attune patella clamps are not holding together well.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint(b)(4).Investigation summary : the device associated with the reported event was not returned for evaluation.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PATELLA DRILL CLAMP
• Type of Device: ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8349648
• MDR Text Key: 136466802
• Report Number: 1818910-2019-84954
• Device Sequence Number: 1
• Product Code: HXD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254501041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1