MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMVAC SINGLE SYRINGE SET; BONE CEMENT : CEMENT DELIVERY DEVICES

Catalog Number 831215

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/27/2020

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

The revision surgery was performed on (b)(6) 2020 via tha.During the surgery, the surgeon used the syringe to agitate 2 pack cements and to inject the cement to bone-marrow cavity.When the surgeon injected the cement with the syringe, the syringe broke into several fragments with explosion noise.Then, the surgeon could not use the syringe, he plunged the cement which was remained in the syringe to bone-marrow cavity by his hand.The surgeon carefully checked that there was no syringe¿s fragment in the body.The surgery was completed, and it was unknown whether there was any surgical delay.No further information is available.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary
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> the complaint states: ¿the revision surgery was performed on (b)(6) 2020 via tha.During the surgery, the surgeon used the syringe to agitate 2 pack cements and to inject the cement to bone-marrow cavity.When the surgeon injected the cement with the syringe, the syringe broke into several fragments with explosion noise.Then, the surgeon could not use the syringe, he plunged the cement which was remained in the syringe to bone-marrow cavity by his hand.The surgeon carefully checked that there was no syringe fragment in the body.The surgery was completed, and it was unknown whether there was any surgical delay.No further information is available." the complaint description indicates that the syringe barrel split at the point where the cement was being injected into the bone cavity.There is insufficient evidence to confirm the complaint description or determine a root cause.Dva-104544-fde rev 6 was reviewed (see attachment pc(b)(4) extract from dva-104544-fde.Pdf), and breakage of syringe making the device inoperable or incomplete extrusion of cement into the patient as a possible failure mode is included on lines 303 to 308.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
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> device history was not available for review as no lot identification details were supplied.

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.

Event Description

Additional information received states that the breakage was broad area of the syringe part without nozzle.It was seemed that the broken fragment did not enter in the body.

• Brand Name: CEMVAC SINGLE SYRINGE SET
• Type of Device: BONE CEMENT : CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10508835
• MDR Text Key: 206187679
• Report Number: 1818910-2020-19669
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 831215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1