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	02/03/2022
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
Whilst opening the insert, the scrub nurse noticed a hole about 1cm long in the inner packaging of the implant.The box and cellophane showed no signs of damage.I have attached photos of the 2 inner packaging.Surgical delay of 5 minutes occurred.No adverse affects on patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : device associated with this report was not received for examination.All available photograph evidence was reviewed and found the package had a cut.It can be determined that device sterility was compromised due to the damage identified.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 158104010, lot number d21061369 was manufactured on 21-jun-2021.44 pcs parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device(product code: 158104010/lot number: d21061369), 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): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13539325
• Report Number: 1818910-2022-02901
• Device Sequence Number: 19787926
• Product Code: NJL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 1581-04-010
• Device Catalogue Number: 158104010
• Device Lot Number: D21061369
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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