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U.S. Department of Health and Human Services

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

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ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 11G END SCP KIT Back to Search Results
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.
 
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Brand NameCPLT F&A KIT 3CC 11G END
Type of DeviceSCP KIT
Manufacturer (Section D)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
MDR Report Key8021127
MDR Text Key125612184
Report Number3008812173-2018-00037
Device Sequence Number1
Product Code OJH
Combination Product (y/n)N
Number of Events Reported1
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 Received10/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/15/2021
Device Model NumberN/A
Device Catalogue Number514.303
Device Lot NumberKC05325
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/03/2018
Device Age2 MO
Event Location Hospital
Date Manufacturer Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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