MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 7 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-710
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
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
Implants came without the original box or cellophane wrap.The implants came open and they can not be used in surgery considering they would not be accepted.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available product photographs were reviewed.Images provided show the reported attune tibial insert in the inner packaging.The outer box can not be seen in the provided images, therefore, investigation can confirm the outer packaging is missing.However, none of the provided pictures show that the inner packaging has been breached, therefore, the investigation can not confirm that the sterility of the device is compromised.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 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.
Event or Problem Description
Additional information received.A.Was surgery time extended? if yes, what was the duration of the delay? no, the incident occurred when the distributor received our implants in his warehouse, at that time the distributor separated the implant so as not to put it in for surgery.B.Was there any adverse consequences that affected the patient because of the reported event? no, the implant did not leave the distributor's office and was not used in any surgery.C.Affected side: the implant came without the outer packaging.
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: no device associated with this report was received for examination.All available product photographs were reviewed.Images provided show the reported attune tibial insert in the inner packaging.The outer box can not be seen in the provided images, therefore, investigation can confirm the outer packaging is missing.However, none of the provided pictures show that the inner packaging has been breached, therefore, the investigation can not confirm that the sterility of the device is compromised.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: 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available product photographs were reviewed.Images provided show the reported attune tibial insert in the inner packaging.The outer box can not be seen in the provided images, therefore, investigation can confirm the outer packaging is missing.However, none of the provided pictures show that the inner packaging has been breached, therefore, the investigation can not confirm that the sterility of the device is compromised.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: 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.,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: ATTUNE PS RP INSRT SZ 7 10MM
• 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: 12623974
• Report Number: 1818910-2021-22674
• Device Sequence Number: 3370341
• Product Code: NJL
• UDI-Device Identifier: 10603295052746
• UDI-Public: 10603295052746
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/30/2021

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 Expiration Date: 07/31/2026
• Device Model Number: 1516-50-710
• Device Catalogue Number: 151650710
• Device Lot Number: 9823308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/20/2021; 12/13/2021; 12/13/2021; 01/24/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 10/20/2021; 12/14/2021; 12/23/2021; 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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