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

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.

• Brand Name: CPLT KNEE KIT 5CC 11G SIDE
• Type of Device: SCP 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 Key: 6731311
• MDR Text Key: 80634941
• Report Number: 3008812173-2017-00019
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC03673
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 06/22/2017; 06/22/2017
• Supplement Dates FDA Received: 09/21/2017; 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR