MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUPORT; CANNULA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, a patient underwent an initial subchondroplasty procedure.Intraoperatively, when the doctor was drilling into the patient's bone with the accuport, the surgeon wanted to change the trajectory of the cannula, so the surgeon backed it out halfway while it was still in the bone and the instrument fractured.The cannula was extracted from the patient, and there were no foreign bodies remaining inside the patient.It is unknown how the cannula was removed.The sales representative attending the case stated that the instrument worked as it should, despite the surgeon error.There were no images provided.It was reported that the patient was fine.The product was not returned for the investigation.Once additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
Broken 307.034 during surgery.
Additional Manufacturer Narrative
A patient underwent the subchondroplasty procedure on december 31st, 2019.The sales representative attending the case was able to speak to the events that had happened.During the surgery, the surgeon wanted to change the trajectory of the cannula; however, the surgeon only backed out the cannula halfway, so it was still halfway in the bone, and when the surgeon went to change the direction, he bent the cannula at an extreme angle, drilled the cannula forward, and the cannula broke.According the sales representative, the instrument worked as it should.This issue is strictly user error due to the surgeon.There were no images taken or provided of the event.The product was not returned for the investigation.The surgeon was able to extract the broken part of the cannula from the patient's bone.The surgery was successfully completed after the removal of the broken cannula.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.Per the accuport ifu, do not bend or exert unnecessary force on cannula during insertion to avoid damaged or broken cannula.Do not attempt to redirect cannula while in bone.Remove the cannula from the bone and redirect to the desired trajectory through the same opening.Avoid creating additional channel to reduce extravasation.This technique was reviewed with the sales representative.
Event or Problem Description
Broken 307.034 during surgery.

• Brand Name: ACCUPORT
• Common Device Name: CANNULA
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9587665
• Report Number: 3008812173-2020-00004
• Device Sequence Number: 2335369
• Product Code: FGY
• UDI-Device Identifier: 00889024205123
• UDI-Public: 00889024205123
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 307.034
• Device Lot Number: 36898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/31/2019
• Device Age: 31 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1