MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 5 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-735

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 12/06/2019

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 on (b)(6) 2019, the left femoral component trial (p/n: 254500735) was broken during the tka for oa at the time of strike after cutting.Because the femoral component trial was inserted in improper position, the surgeon struck the femoral component trial with an impactor, and the femoral component trial broke.The surgery was completed successfully, and there was no fragment in the patient.The surgery was delayed by less than 30minutes.The surgeon commented that there was a possible that the attune instruments and implants didn¿t have enough strength to be used in the surgery.No further information is available.

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.H10 additional narrative: corrected: h3 and h6: product complaint # : (b)(4).Investigation summary :examination of the returned device confirms the reported event of trial breakage.The root cause is attributed to user technique and/or misuse.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 PS FEM TRIAL SZ 5 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9521309
• MDR Text Key: 188323939
• Report Number: 1818910-2019-124730
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 10603295134077
• UDI-Public: 10603295134077
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-735
• Device Catalogue Number: 254500735
• Device Lot Number: MVMBWZ040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1