MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 VMP ENDURANCE 80G; BONE CEMENT : BONE CEMENT

Catalog Number 3172080

Device Problems Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 monomer of the cement (p/n: 3172080) flow only about half amount into the syringe when the surgeon put it in the funnel potion at the top of the paddle during the surgery on (b)(6) 2019 and could not be used.The surgery was completed within a 30 minutes surgical delay and there was no adverse consequence to the patient.No further information is available.

Manufacturer Narrative

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.Additional narrative: added: evaluation codes (functional; cement consistency).Product complaint # (b)(4).Investigation summary:the complaint states: ¿it was reported that the monomer of the cement (p/n: 3172080) flow only about half amount into the syringe when the surgeon put it in the funnel potion at the top of the paddle during the surgery on (b)(6) 2019 and could not be used.The surgery was completed within a 30 minutes surgical delay and there was no adverse consequence to the patient.No further information is available.¿ the syringe has not been returned for examination, and no photographs have been made available for investigation.(b)(4) rev c was reviewed, and the relevant instructions are included in the ¿mixing and application¿ section, step numbers 4 to 9.Step 4 states ¿the mixing cap and funnel are fitted into the syringe barrel ensuring that the handle is fully lowered.¿ step 7 requires that once the monomer has been added via the funnel ¿the snap off plug is fully inserted into the hole in the handle, thus sealing off the mixing chamber¿.The handle should not be in the raised position until mixing commences at step 8.The handle is lowered again for step 9.The instructions match the diagrammatic flow in the ifu.(b)(4) rev 10 was reviewed for this failure mode; monomer being drawn down the vacuum tube is included on line 485 as part of the overall function of the mixing system.The risk is considered ¿as low as possible¿ and cannot be further mitigated.See attachment ¿(b)(4) extract from (b)(4)¿.In conclusion, there is insufficient evidence to determine the root cause for this complaint, but it is likely that user error has resulted in the failure mode described in the complaint description.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.Depuy synthes considers the investigation closed at this time.Should additional information be received, a review of the information will be completed, and the investigation may be re-opened as required.Device history lot : device history reviewed 11 november 2019.0 non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 30 june 2020.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VMP ENDURANCE 80G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8577823
• MDR Text Key: 144256664
• Report Number: 1818910-2019-92420
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3172080
• Device Lot Number: 8867749
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1