MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 3 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-308
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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 the implant arrived with the cellophane, but when we opened the box we noticed that the labels did not match the box.For this reason, the implant was not opened.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for analysis.Photo evidence provided was reviewed and found this device was associated due its labeling being found placed under (b)(4), however, the actual device is not present in the complaint evidence provided.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: product code 151630308, work order (b)(4) was manufactured on 26-nov-2019.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: 2 parts from this lot were scrapped: scrap code a001: this concerns black spot/imbedded particle.There is no correlation between this scrap reason and the failure mode of the complaint.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.Device history review: manufactured on 26-nov-2019.(b)(4) parts were manufactured scrap: 2 parts scrap code a001: this concerns black spot/imbedded particle.Non-conformance: none, reprocessing: none.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Photo evidence provided was reviewed and found this device was associated due its labeling being found placed under (b)(4), however, the actual device is not present in the complaint evidence provided.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 : product code 151630308, work order (b)(4) was manufactured on 26-nov-2019.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: 2 parts from this lot were scrapped: scrap code a001: this concerns black spot/imbedded particle.There is no correlation between this scrap reason and the failure mode of the complaint.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.

• Brand Name: ATTUNE CR RP INSRT SZ 3 8MM
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14218895
• Report Number: 1818910-2022-07678
• Device Sequence Number: 4137719
• Product Code: NJL
• UDI-Device Identifier: 10603295047537
• UDI-Public: 10603295047537
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/27/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 10/31/2024
• Device Model Number: 1516-30-308
• Device Catalogue Number: 151630308
• Device Lot Number: 9341682
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 10/31/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 10/27/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR RP INSRT SZ 3 8MM; ATTUNE PS RP INSRT SZ4 6MM
• Patient Sex: Unknown