MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CEMENT DELIVERY DEVICE

Catalog Number UNK CEMENT DELIVERY DEVICE

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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

The primary surgery was performed on (b)(6) 2020 via tka with the cement (p/n: (b)(4)).During the surgery, the surgeon could not inject azoto because the connecting point of the cement's hose which was connecting the syringe to foot pump had broken.The surgery was completed with backup devices and there was no surgical delay.There was no harm to the patient.No further information is available.

Manufacturer Narrative

Product complaint # :(b)(4) investigation summary
=
> the complaint states: ¿the primary surgery was performed on (b)(6), 2020 via tka with the cement (p/n: (b)(4) ).During the surgery, the surgeon could not inject azoto because the connecting point of the cement's hose which was connecting the syringe to foot pump had broken.The surgery was completed with backup devices and there was no surgical delay.There was no harm to the patient.No further information is available.¿ the complaint description implies that the carbon filter (¿the connecting point pf the cement¿s hose¿) was broken during use.The carbon filter is a component part of product code 3172050, not a separate device.No physical sample or photographs have been supplied to support the complaint description.The complaint description cannot be confirmed and there is insufficient information to determine root cause.Dva-104409-fde rev 10 was reviewed, and this potential failure is included on lines 360-363 (see attachment ¿(b)(4) extract from dva-104409-fde.Pdf¿).In each case, the risk is considered ¿as low as possible¿ and cannot be further mitigated.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, the information will be reviewed and the investigation may be re-opened as required.Device history lot
=
> unknown device - no device history to review.

• Brand Name: UNK CEMENT DELIVERY DEVICE
• Type of Device: UNK CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9982021
• MDR Text Key: 188723653
• Report Number: 1818910-2020-11082
• Device Sequence Number: 1
• Product Code: KIH
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT DELIVERY DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VMP ENDURANCE 50G