MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY; SCP KIT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

While conducting the march maude database search on (b)(6) 2020, a new event was found to be in the system and not directly reported to zkc.The report number was identified as mw5092944.The event date was reported as (b)(6) 2020 for a malfunction.The report date was (b)(6) 2020, and the date the fda received the report was (b)(6) 2020.The reporter and location of the event were not indicated on the report.The event was for the tip of an accuport cannula broke off into the bone.The physician did not chose to extract it.The report stated that the instrument was available for investigation.Once additional information about the event becomes available, an additional report will be submitted.

Event Description

Fractured cannula tip remains in patient's bone.

Manufacturer Narrative

As a part of zimmer knee creations capa ca-05425, it was identified that the incorrect part number was initially submitted.This follow up report is being submitted to correct the part number reported.

Event Description

Fractured cannula tip remains in patient's bone.

Event Description

Fracture of cannula tip in bone.

Manufacturer Narrative

Maude report stated that tip of an accuport cannula (part number 307.032 and lot number 41317) broke off during surgery and was retained in the patient's bone.The physician did not choose to extract it.The maude report did not state the location/facility of the event, patient information, contact information, etc., therefore, follow-up cannot be completed.This complaint will be logged in order to identify possible trends.Due to the lack of information, a definitive root cause cannot be determined.The risk has been accounted for in the accuport risk analyses.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.Per the accuport ifu, 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.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9954924
• MDR Text Key: 191540129
• Report Number: 3008812173-2020-00009
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00088024205116
• UDI-Public: 0088024205116
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020,10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC06078
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 02/11/2020
• Device Age: 14 MO
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PN 414.502LN KC06078
• Patient Outcome(s): Other