• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT KNEE KIT 5CC 11G SIDE SCP KNEE KIT WITH SIDE DELIVERY 11 GA ACCUPORT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER KNEE CREATIONS, INC. CPLT KNEE KIT 5CC 11G SIDE SCP KNEE KIT WITH SIDE DELIVERY 11 GA ACCUPORT Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/22/2017
Event Type  Injury  
Manufacturer Narrative

Currently this complaint is in the investigation process and it is not complete. A supplemental medwatch will be submitted once more information is available. Not returned.

 
Event Description

Broken cannula tip retained in femur.

 
Manufacturer Narrative

Per the investigation, it was found that the surgeon drilled the cannula into the bone, manipulated the patient's leg to about 70 degrees while the cannula while was still in the body, and as a result, the cannula broke. Per the ifu, guidance is given, ¿use proper technique to remove cannula from bone to avoid damaged or broken cannula. Fully insert stylus into cannula, then remove stylus and cannula with surgical drill in reverse. ¿ per the health care professional, the broken fragment remains in the patient; follow-up was conducted and the patient responded well to the surgery.

 
Event Description

Broken cannula tip retained in femur.

 
Manufacturer Narrative

Regarding dr. (b)(6) case, the representative that filed this complaint, (b)(6), was contacted and asked to recount the events surrounding the failure. He replied that he was not actually in the case, and that (b)(6) is the rep that should be followed up with. The investigator was able to follow up with mr. (b)(6) and dr. (b)(6). Nothing about the patient was pointed out as being out of the ordinary aside from the leg being on the larger side of things. The bone quality and ability to drill was noted as being normal and the surgeon was not required to redirect the pin, nor did he bump in to it at any point. The surgeon was able to inject about 4. 5cc of bsm before plunging the cannula with the stylus. The surgeon commented that he was diligent about clicking the stylus back into the cannula; he uses the white line to be aware of the injection direction during surgery and watches that part of the instrument. The case proceeded normally until the surgeon was performing the arthroscopy. During that phase of the procedure, dr. (b)(6) commented that he heard a ¿pop. ¿ he further explained that it was at the point where the leg was flexed to about 70deg; the accuport® instrument had been drilled into the patient with the leg in full extension. After removing the cannula, dr. (b)(6) saw that the cannula had broken at the 2nd fenestration. He used the mini c-arm to confirm that the other piece of the instrument was still inside the bone. He determined that it would cause more harm to try to remove the piece than to leave it in. This resulted in a delay of surgery less than 5 min, and the accuport® instrument was disposed of in the sharps bin. Dr. (b)(6) stated that the patient had a thick subcutaneous layer of skin and believes that during the arthroscopy, that skin became taught and bent/broke the cannula. He also stated that the patient is responding very well to the surgery. A review of the risk dfmea (risk 307. 000-b) was conducted. It confirmed that the failure mode for this event already exists; see rsk 307. 000-13 loss of mechanical integrity. Of the four potential causes, two are considered acceptable and the other two are undesirable. The undesirable causes have an associated clinical risk assessment completed as a rationale for no further mitigation. As the failure mode has already been addressed, no corrective action will be taken at this time. The lot¿s dhr was also reviewed and found to have no deviations that would indicate a weakening of the area that resulted in a breakage. Additionally, a retain of the same lot was reviewed. It was found that the threading width was larger than allowed by the drawing (0. 25mm upper limit, 0. 36mm measured). White this may have contributed to the failure, it cannot be sited as the cause of the failure because the actual part was not returned. The surgeon is confident that the breakage occurred as a result of the skin pulling on the accuport® instrument during the arthroscopic portion of the case, and nothing in this investigation disproves that theory. However, as the instrument could not be analyzed - because it was disposed of - and the investigator was not present in the surgery, the definitive cause of this failure could not be confirmed. At this point, the cause of this failure is unknown.

 
Event Description

Broken cannula tip retained in femur.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCPLT KNEE KIT 5CC 11G SIDE
Type of DeviceSCP KNEE KIT WITH SIDE DELIVERY 11 GA ACCUPORT
Manufacturer (Section D)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
Manufacturer (Section G)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
Manufacturer Contact
shari bailey
841 springdale drive
exton, PA 19341
4848794543
MDR Report Key6731311
MDR Text Key80634941
Report Number3008812173-2017-00019
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/19/2019
Device MODEL NumberN/A
Device Catalogue Number414.502
Device LOT NumberKC03673
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/09/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 07/21/2017 Patient Sequence Number: 1
-
-