MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PLI GVF INS 4 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-04-010
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Event date: (b)(6) 2021.Event description: opened the sterile packaging and the implant packet had a hole in and seal had been broken.Not present during the case but no harm to patient or delay in surgery.
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).Investigation summary: no device associated with this report was received for examination.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 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: a manufacturing record evaluation (nc search) was performed for the finished device 158104010, lot d21042588, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SIGMA PLI GVF INS 4 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 12828376
• Report Number: 1818910-2021-25335
• Device Sequence Number: 4425642
• Product Code: JWH
• UDI-Device Identifier: 10603295062615
• UDI-Public: 10603295062615
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: 03/31/2026
• Device Model Number: 1581-04-010
• Device Catalogue Number: 158104010
• Device Lot Number: D21042588
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown