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 01/10/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, during a subchondroplasty procedure, an accuport cannula was inserted into the medial femoral condyle and medial tibial plateau under fluoroscopic guidance.After injection of the accufill through the cannula, the cannula was left in place for 8 minutes per manufacturer specifications while the implant hardened.As the cannula was being removed from the femur, the tip broke off and was left within the condyle.It was noted that during the setting time, the surgeon moved the leg while the cannula was still inside the patient.No extravasation was noted, and the cannula tip was not intra-articular as confirmed by arthroscope.The surgeon had decided to leave the piece of cannula in the patient.The patient was noted as fine, and the surgery was completed successfully.The event was forwarded to zimmer knee creations on (b)(6) 2020 via medwatch form mrf report number 050351000-2020-01.The product was not returned for evaluation; however, a retained sample from the same lot was available for investigation, and the product was determined to be in accordance with specification.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.Per the scp surgical technique guide knee free hand technique, after injection, the scope also allows evaluation for and evacuation of any material that has extravasated into the joint.Note, however, that while the accuport injection cannulas are in place, take care while manipulating the knee during scoping, to avoid bending forces on the cannula that may damage the cannula or surrounding bone.This technique was reviewed with the sales representative.

Event Description

Broken tip of cannula 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

Broken tip of cannula remains in patient's bone.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9728691
• MDR Text Key: 182700489
• Report Number: 3008812173-2020-00005
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205116
• UDI-Public: 0889024205116
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2020,10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC06256
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/13/2020
• Distributor Facility Aware Date: 01/10/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2020
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR