MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE INST SZ 9-10; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Catalog Number	254501709
Medical Device Problem Codes	Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
Event or Problem Description
It was reported that the paint/marking coming off brand new instrument pans, during washing and drying.
Additional Manufacturer Narrative
Product complaint (b)(4)investigation summary according to the information received, "it was reported that the paint/marking coming off brand new instrument pans, during washing and drying" follow-up with the sales rep for additional information regarding the cleaning and drying methods used was unsuccessful.The product was not returned to depuy synthes, however photos were provided for review.See attachment ((b)(4) the photo investigation revealed that the device (b)(4), attune inst sz 9-10 had peeling coating but provided photograph did not reveal foreign substance associated with the device.No further evidence can be observed from the photo to determine the root cause.The overall complaint was confirmed as the observed condition of the device (b)(4), attune inst sz 9-10 would contribute to the complained device issue.Based on the investigation findings, 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 the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ATTUNE INST SZ 9-10
• Common Device Name: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17956771
• Report Number: 1818910-2023-21258
• Device Sequence Number: 12514299
• Product Code: FSM
• UDI-Device Identifier: 10603295423591
• UDI-Public: 10603295423591
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254501709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown