MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Catalog Number 254401004

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 attune femoral impactor red spin dial broke off the side of the impactor while the femoral implant was being impacted down.The attune rp impactor broke into 2 pieces when the tibial implant was being impacted down.The attune femoral impactor also broke into two pieces when the trial femur was being put on the femur for trialing.No adverse event occurred to the patient.The doctor does not wish to be contacted.No surgical delay.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Root cause and corrective action are documented in the capa system.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.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.

• Brand Name: ATTUNE RP TIBIAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8903237
• MDR Text Key: 154634528
• Report Number: 1818910-2019-101415
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130208
• UDI-Public: 10603295130208
• 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: 07/29/2019

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: 254401004
• Device Lot Number: AU6351763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1