MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problem Difficult to Open or Remove Packaging Material (2922)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.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 Description

It was reported that the bag with the powder-component sticks to outer packaging and cannot be removed.No adverse patient consequences, no surgical delay reported.

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
=
> bfarm dhr review: product code: 3095040 lot number: 3660082 1) quantity manufactured: (b)(4) 2) date of manufacture: 12/09/2021 3) any anomalies or deviations identified in dhr: none 4) expiry date: 11/30/2023 5) ifu reference: ifu-0630132 device history review
=
> a manufacturing record evaluation was performed for the finished device (3095040/3660082) product and lot numbers, and no non-conformances were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not received for examination.However the product and lot# associated with this complaint is under investigation and we have found that the cement powder inner bag is overlapping with the paper outer foil for other cements in this same lot#.Additionally we have not found any compromise in the sterility and/or the product.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Device history lot : product code: 3095040, lot number: 3660082.1) quantity manufactured: (b)(4), 2) date of manufacture: 12/09/2021, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 11/30/2023, 5) ifu reference: ifu-0630132.A search of the depuy nonconformance (nc) quality system found no past nc¿s associated with this product/lot combination.An nc has been raised to address the current complaint condition.Device history review : 1) quantity manufactured: (b)(4), 2) date of manufacture: 12/09/2021, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 11/30/2023, 5) ifu reference: ifu-0630132.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15156396
• MDR Text Key: 304610235
• Report Number: 1818910-2022-14882
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 3095040
• Device Lot Number: 3660082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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