MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTMIX CEMVAC SYRINGE; CEMENT DELIVERY DEVICES

Catalog Number 831615P

Device Problems Break (1069); Off-Label Use (1494)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

Event occurred during revision surgery.After the cement was stirred, the surgeon started to inject the cement at the timing judged to be appropriate viscosity.As there was more resistance during cement injection than expected, the surgeon pulled the trigger of the gun with some force and the syringe ruptured.Since the cement had already been injected in the distal region at that time, it was difficult to redo the procedure.The surgeon applied the cement spilled from the syringe to the stem and inserted the stem.Because that operation became cumbersome, the cement eventually hardened with the distal stem (about 1/3) protruding from the fracture line to the outside of the medullary cavity.But this time, the surgeon decided to finish the surgery.Surgical delay of 30 minutes occurred.

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.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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 the device associated with this report was returned for analysis.Visual inspection of the device found the tip of the syringe cut and the hole needle broken of from the device.Additionally, the syringe barrel had a huge crack.Off label used was identified.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 necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.

• Brand Name: SMARTMIX CEMVAC SYRINGE
• Type of Device: CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14578003
• MDR Text Key: 293192897
• Report Number: 1818910-2022-09990
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 831615P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CEMVAC ULTRA CEMENT GUN; REVISION NOZZLE (6.5MM); UNKNOWN HIP FEMORAL STEM
• Patient Sex: Male