MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problem Chemical Problem (2893)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Mf#- 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.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 Description

It was reported that the gmv cement hardened too quickly and was not able to shoot in a cement gun.There was a surgical delay for 10-15 minutes.

Event Description

Additional information received.A.How was the cement prepared for use? -it was mixed in a mixing tower for 1 minute.It was then mixed for 30 seconds in a mixing tower the next attempts & still hardened too quickly before putting into a cement gun.B.What equipment was used to prepare / mix the cement? -hospital-owned stryker mixing tower c.What was the timing to mix and the time between mixing and setting? -mix was 1 minute and time between mixing and setting was 2-3 minutes.D.What equipment was used to deliver the cement? -was going to be a cement gun e.Can you provide the quantity used of the cement product? qty of 5 was used in the procedure.

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: a1, a3, b5 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).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 : it was reported that the gmv cement hardened too quickly and was not able to shoot in a cement gun.This happened in 3 attempts mixing cement during the case.Afterwards a total mix was done with a batch of cement and the same thing happened.It's almost like the gmv cement is acting like the ghv cement.There was a surgical delay for 10-15 minutes.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the smartset gmv 40g us eo [545050501/4047303].The device was received on the original packaging closed.The retain sample test revealed that the cement mixed and behaved as expected for the product type and met the appropriate control specification.Refer to full report "lot.4047303 investigation report".A dimensional for the smartset gmv 40g us eo was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the smartset gmv 40g us eo [545050501/4047303] was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history lot : a manufacturing record evaluation was performed for the finished device [545050501/4047303] and no non conformances or manufacturing irregularities were identified.".

• Brand Name: SMARTSET GMV 40G US EO
• 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: 17649688
• MDR Text Key: 322259747
• Report Number: 1818910-2023-17781
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 4047303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• 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
• Patient Sex: Female