MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 7 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-737

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

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 component is scratched.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - examination of the returned device confirmed the reported damage.The investigation attributed the root cause to unintended user error and the need for corrective action was not indicated.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 h10 additional narrative: h6 component code: part/component/sub-assembly term not applicable (g07001) is used to capture visual: scratched/nicked.Corrected: h3.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE PS FEM TRIAL SZ 7 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10793682
• MDR Text Key: 215037348
• Report Number: 1818910-2020-24042
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295134091
• UDI-Public: 10603295134091
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

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 Model Number: 2545-00-737
• Device Catalogue Number: 254500737
• Device Lot Number: MVMCDL730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 10/31/2020; 11/30/2020
• Supplement Dates FDA Received: 11/11/2020; 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1