MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SIG HP REV FEMORAL TRIAL CASE; KNEE INSTRUMENT : INSTRUMENT CASES

Catalog Number	201103050
Medical Device Problem Codes	Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
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 instrument trays are flaking and peeling.There were no affects to the patients and no surgery delays.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
Additional 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 that 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- it was reported that the instrument trays are flaking & peeling.Facility seems them contaminated for procedures and cannot be used.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the plastic coating had begun to separate, with signs of wear and corrosion likely due to repetitive sterilization cycles.Additionally, a yellowish substance was found on the augment trials carriers.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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.Corrosion/oxidation is identified around the surface of the device, alongside damage consistent with normal wear, this suggests that the passive layer of the metal has been worn down from repeated use (due to normal use damage) allowing for the metallic surface underneath to become susceptible to corrosion/oxidation.Therefore, the potential cause of the observed corrosion/oxidation is consistent with the device reaching the end of its useful life.Foreign substance on the device may have occurred during the cleaning or sterilization process.However, without concrete evidence or more detailed information, as well as the specific substance in question, it is not possible to definitively determine the root cause of this condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of sig hp rev femoral trial case would have contributed to the complained 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 reported 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG HP REV FEMORAL TRIAL CASE
• Common Device Name: KNEE INSTRUMENT : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 19582777
• Report Number: 1818910-2024-13531
• Device Sequence Number: 19709476
• Product Code: FSM
• UDI-Device Identifier: 10603295081692
• UDI-Public: (01)10603295081692(10)PV0033276
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup,Followup
• Report Date (Section B): 06/21/2024

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: 201103050
• Device Lot Number: PV0033276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/05/2024; 08/08/2024; 10/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/08/2024; 08/12/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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