MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ2; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6022
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	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Inner packing deformed&unsealed.It was reported that during the surgery of left total knee arthroplasty, checked the out-box, it was complete good, opened it, noted the 1st inner packing was deformed but sealed, opened the 1st inner packing, noted the 2nd inner packing was also deformed and unsealed as the photos show.No back-up device on site,so used iodophor to soak the device, then implant into the patient.The patient is stable and in hospital now.Surgery delayed about 20 minutes.
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.H10 additional narrative:  added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected; h3, h8.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : examination of the returned device and photograph confirm the reported event that the packaging is deformed, but could not confirm the reported compromised sterility.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 review was completed of the device history record (dhr) and operations management system (oms) for the following: product code 866022, work order (b)(4) was manufactured on 10 june 2021.All raw materials met specification.(b)(4) parts were manufactured to specification.

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ2
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11919231
• Report Number: 1818910-2021-11526
• Device Sequence Number: 3179886
• Product Code: JWH
• UDI-Device Identifier: 10603295216773
• UDI-Public: 10603295216773
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2021

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 Model Number: 86-6022
• Device Catalogue Number: 866022
• Device Lot Number: 9539514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 08/27/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/18/2021; 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 62