MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number	5450-31-500
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	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Component code: appropriate term/code not available (g07002) used to capture no findings available.Dmf# - 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.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.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 cement had a contaminated packaging.No effect to patient.The surgeon was planning to use the defective package but when the nurse opened the box of cement, noticed the product could not be considered sterile.The product was wasted due to a tear/hole in the plastic packaging, which exposed the sterile cement.The hole was located at the edge/end that was used to open the package just before the sterile part of the product.No surgical delay.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16512062
• Report Number: 1818910-2023-05417
• Device Sequence Number: 6381933
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: 5450-31-500
• Device Catalogue Number: 545031500
• Device Lot Number: 9647102
• 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: 02/22/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• 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 Age: 59 YR
• Patient Sex: Male