MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410105
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, the product in question was planned to be used in the surgery via tka for oa on knee.In the surgery, the foreign substance was found by the surgeon.Since there was a spare, it was opened and used instead.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "it was reported that on oct.3, 2023, the product in question was planned to be used in the surgery via tka for oa on knee.In the surgery, the foreign substance was found by the surgeon.Since there was a spare, it was opened and used instead.The surgery was completed successfully within 30 minutes surgical delay.No further information is available".The product and photos were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device and attachment "photo_(b)(4)_(b)(6) hospital (jo202300477)".The depuy synthes team forwarded the device and photos to the depuy cork which conducted a manufacturing investigation.Visual analysis of the returned sample revealed that a foreign material, similar to a thread/shaving was found on the inner tyvek of the involved attune ps fem lt sz 5 cem.The foreign material appeared to be a red shaving but it was not possible to determine the properties of the material; it is wort mentioning that the seal remained intact and the tyvek was not compromised.Based on the manufacturing investigation findings, the root cause of the observed condition of the packaged cannot be attributed to a manufacturing issue and no action is required.The source of the red fiber could not be confirmed to have originated from the manufacturing environment and may have entered the packaging when opened in the field.Refer to the attachment "investigation memo for (b)(4) revision 2 (2).Pdf" for the investigation report.A manufacturing record evaluation was performed for the finished device [150410105 / 3851810] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the attune ps fem lt sz 5 cem 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 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 : a manufacturing record evaluation was performed for the finished device [150410105 / 3851810] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
Additional Manufacturer Narrative
Product complaint (b)(4).Corrected: h3.

• Brand Name: ATTUNE PS FEM LT SZ 5 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17929635
• Report Number: 1818910-2023-20863
• Device Sequence Number: 6595587
• Product Code: JWH
• UDI-Device Identifier: 10603295041627
• UDI-Public: 10603295041627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2023

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: 150410105
• Device Lot Number: 3851810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 04/08/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/18/2024; 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown