MAUDE Adverse Event Report: DEPUY CMW - 9610921 VMP + DEPUY CMW 3G 50G; BONE CEMENT : BONE CEMENT

Catalog Number 3005050

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

The tapes on the cement bag had damaged.No patient involved.

Manufacturer Narrative

Product complaint # :(b)(4).Dmf# - (b)(4).Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received indicated that the package of the cement was damaged.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device associated with this report was received for examination.Damaged packaging complaint is confirmed.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
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> a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

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.

• Brand Name: VMP + DEPUY CMW 3G 50G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12892187
• MDR Text Key: 281407416
• Report Number: 1818910-2021-26479
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 3005050
• Device Lot Number: 9857330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/07/2021; 01/27/2022; 02/11/2022
• Supplement Dates FDA Received: 12/13/2021; 02/10/2022; 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1