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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Broken tip of cannula remains in patient's bone.
Additional 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 or Problem Description
Broken tip of cannula remains in patient's bone.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9728691
• Report Number: 3008812173-2020-00005
• Device Sequence Number: 3281425
• Product Code: OJH
• UDI-Device Identifier: 00889024205116
• UDI-Public: 0889024205116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020
• Report Date (Section F): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Distributor Facility Aware Date: 01/10/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/13/2020