MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ3 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-305
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	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent the tka surgery for oa.During the surgery, an operation staff found a hair inside the package of the attune insert.The hair was not found immediately after the package was opened.Since the implant was prepared and left for a while, the staff did not know whether the hair was contaminated originally or during the surgery.In the surgery, another product of the same size was used.The surgery was completed successfully with no surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned.After photographic review of the hair's detection, allegation is confirmed.Observations on the evidence showed a hair on the inner packaging of the device.Visual examination of the returned package showed that sterile pouch remained sealed and implant stills inside it.Since package was opened and left for a while at the operating room it cannot be determined how did the hair got onto the tyvek lid.The hair was retrieved from the detection area and it was returned in a sterile bag apart from the rest of package.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 151650305, work order (b)(4) was manufactured on 11 december 2019.A total of (b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with lot 9364879.Reprocessing: there was no material reprocessing reports (mrr) associated with lot 9364879.Non-conformance: there were no non-conformances associated with lot 9364879 device history review: a manufacturing record evaluation was performed for the finished device (151650305/9364879) product and lot numbers, and no non-conformances were identified.

• Brand Name: ATTUNE PS RP INSRT SZ3 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13860386
• Report Number: 1818910-2022-05170
• Device Sequence Number: 4692935
• Product Code: NJL
• UDI-Device Identifier: 10603295052142
• UDI-Public: 10603295052142
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2022

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 Model Number: 1516-50-305
• Device Catalogue Number: 151650305
• Device Lot Number: 9364879
• 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: 03/06/2022
• Supplement Date Received by Manufacturer: 04/18/2022; 06/03/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/19/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown