MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT

Catalog Number	3322020
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that while opening a box of cement, a hair was noticed inside the packaging of the monomer.A new package was used and there was no delay of case.The procedure was successfully completed.There was no patient consequence.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: while opening a box of cement a hair was noticed inside the packaging of the monomer.A new package was used and there was no delay of case.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found a hair inside the packaging.A manufacturing record evaluation was performed and no non-conformances or manufacturing irregularities were identified that would contribute to the reported allegation.However, a nr has been raised for further investigation details.A definite root cause cannot be established at the moment.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the depuy cmw 2 20g would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue was addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: (b)(4) has been created by j&j medtech orthopedic quality management system to address the current complaint condition.Device history review: (b)(4) has been created by j&j medtech orthopedic quality management system to address the current complaint condition.H11 additional narrative: corrected: d3, g1 (manufacturing site name), h3.

• Brand Name: DEPUY CMW 2 20G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool ; UK
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21675774
• Report Number: 1818910-2025-04094
• Device Sequence Number: 7693153
• Product Code: LOD
• UDI-Device Identifier: 10603295168621
• UDI-Public: (01)10603295168621(17)270630(10)4530014
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053003
• 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,Followup,Followup
• Report Date (Section B): 05/21/2025

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 Catalogue Number: 3322020
• Device Lot Number: 4530014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 05/20/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/03/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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