MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 11G END SCP KIT

Model Number N/A

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

After drilling the cannula into the talus without toggle, the surgeon confirmed by touching the cannula that it was not hot. However, the accufill failed to flow through the cannula. This resulted in a delay of about 30-45 minutes. There was no reported impact to the patient as a result of the delay. The device was not returned, as it was discarded at the hospital. A second kit was used, the accufill was able to flow appropriately, and the surgery was completed successfully. Once additional information becomes available, a supplemental report will be submitted.

Event Description

Accufill would not flow through cannula.

Manufacturer Narrative

After drilling the cannula into the talus without toggle, the surgeon confirmed by touching the cannula that it was not hot. However, the accufill failed to flow through the cannula. This resulted in a delay of about 30-45 minutes. There was no reported impact to the patient as a result of the delay. The device was not returned, as it was discarded at the hospital. During the investigation, it was noted that the patient had particularly hard bone, which may have attributed to the heating of the cannula. After second kit was used, the accufill was able to flow appropriately, and the surgery was completed successfully. The investigation engineer reviewed the case and surgical technique with the sales representative to cool the accuport with 2cc of saline per the surgical technique guide if heat is generated while drilling into the bone.

Event Description

Accufill would not flow through cannula.

• Brand Name: CPLT F&A KIT 3CC 11G END
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8021127
• MDR Text Key: 125612184
• Report Number: 3008812173-2018-00037
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/15/2021
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Device Lot Number: KC05325
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/03/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A