MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA TIB TRAY CEM SZ3; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6023
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the sterile packed inside plastic box was stuck to the outside plastic box.
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 866023, lot d22050767, and no non-conformances / manufacturing irregularities were identified.Corrected: h8.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: device associated with this report was received for examination at depuy suzhou manufacturing and found that the tyvek was ripped off and was not returned.Deformation was found on the blister.Including the blister body and flange area.In addition, it was found that there are some traces of sleeve adhesion on the outside of outer blister, this condition makes the packaging difficult to open.Compromised sterility cannot be confirmed since tyvek lid flange was adhered to the inner blister flange as intended.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 manufacturing record evaluation (nc search) was performed for the finished device 866023, lot d22050767, and no non-conformances / manufacturing irregularities were identified.Device history review: product code 866023; lot number d22050767; mfg date: 31-may-2022.(b)(4) parts manufactured per specification and all raw material met specification.No non-conformances were identified.The expiry date is 30-apr-2032.Ifu reference no.Is ifu-0902-00-886.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: device associated with this report was received for examination at depuy suzhou manufacturing and found that the tyvek was ripped off and was not returned.Deformation was found on the blister.Including the blister body and flange area.In addition, it was found that there are some traces of sleeve adhesion on the outside of outer blister, this condition makes the packaging difficult to open.Compromised sterility cannot be confirmed since tyvek lid flange was adhered to the inner blister flange as intended.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 manufacturing record evaluation (nc search) was performed for the finished device 866023, lot d22050767, and no non-conformances / manufacturing irregularities were identified.Device history review: product code 866023 lot number d22050767 mfg date: 31-may-2022.24 pcs parts manufactured per specification and all raw material met specification.No non-conformances were identified.The expiry date is 30-apr-2032.Ifu reference no.Is ifu-0902-00-886.

• Brand Name: PFC SIGMA TIB TRAY CEM SZ3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15157722
• Report Number: 1818910-2022-14916
• Device Sequence Number: 14751434
• Product Code: JWH
• UDI-Device Identifier: 10603295216780
• UDI-Public: 10603295216780
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K884796
• 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,Followup
• Report Date (Section B): 08/03/2022

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: 86-6023
• Device Catalogue Number: 866023
• Device Lot Number: D22050767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 10/14/2022; 08/09/2023
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/17/2022; 10/17/2022; 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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