MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SYSTEM IMPACTOR; IMPACTORS

Catalog Number 254411003

Device Problems Naturally Worn (2988); Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Hcp is reporting a defective instrument without telling details.Additional event information reports instruments have scratches and pressure marks in the same place, so that the plastic overlaps each other.

Manufacturer Narrative

Product complaint # (b)(4).Date of event is an unknown date.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "hcp is reporting a defective instrument without telling details." the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4) photo.The photo/x-ray investigation revealed that attune system impactor had stripped/worn/twisted/cross threaded & scratched/nicked.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune system impactor would contribute to the complained device issue.Based on the investigation findings, end of life problem identified and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : device history record review for: product description: attune system impactor product code: 254411003 lot number:bfa2b21.1) quantity manufactured: 96 2) date of manufacture: 04/06/2023 3) any anomalies or deviations identified in dhr: none 5) ifu reference:(b)(4).

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.The expiration date (9/4/2050) in the initial medwatch was reported in error.The device involved was an instrument and does not have an expiration date.

Event Description

Additional information received indicates that the damage probably occurred in the operating theatre, as such damage is not caused during reprocessing.

• Brand Name: ATTUNE SYSTEM IMPACTOR
• Type of Device: IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18992924
• MDR Text Key: 338883092
• Report Number: 1818910-2024-06945
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295493549
• UDI-Public: 10603295493549
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254411003
• Device Lot Number: BFA2B21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1