MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 2 CEM; KNEE TIBIAL TRAY

Model Number	1506-80-002
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent tka for oa with the tibial tray in question.During surgery, the surgeon found dirt on the surface of the tibial tray.He didn't use the tibial tray and opened the new tibial tray.However, the new tibial tray also had dirt on its surface.The surgeon wiped the dirt off and used it.The surgeon found the dirt without touching the surface of the tray.The surgery was completed successfully and there was 30 min 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.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 reported event could not be confirmed as the device was returned without discernable markings matching that of the event description.The polished surface of the device is smudged consistent with finger markings and other surface level scratches attributed to the handling of the device after the tibial protective cover was removed.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a device history record (dhr) review was conducted by the manufacturing site.Product code 150680002, work order (b)(4) attune rp tib base sz 2 cem was manufactured on 21-nov-2020.20 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no reprocessing associated with this lot.Non-conformance: there was no non-conformance associated with this lot.Corrected: h3.

• Brand Name: ATTUNE RP TIB BASE SZ 2 CEM
• Common Device Name: KNEE TIBIAL TRAY
• 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: 12142473
• Report Number: 1818910-2021-14809
• Device Sequence Number: 4259907
• Product Code: JWH
• UDI-Device Identifier: 10603295492146
• UDI-Public: 10603295492146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/18/2021

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: 1506-80-002
• Device Catalogue Number: 150680002
• Device Lot Number: 9646765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 12/23/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/29/2021; 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE RP TIB BASE SZ 2 CEM.; ATTUNE RP TIB BASE SZ 2 CEM.; ATTUNE RP TIB BASE SZ 2 CEM; ATTUNE RP TIB BASE SZ 2 CEM
• Patient Sex: Unknown