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 11/04/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, zimmer knee creations was notified of an event that occurred on (b)(6) 2019.It was reported that the tip of the cannula being used broke off at the fenestrations and was retained in the patient's distal femur.There are currently no pictures or xrays related to the event that are available.The device was not returned, as the tip was left in the patient and the rest of it was discarded by the user facility a review of the finished good dhr was conducted and there were no anomalies related to the complaint condition.Once additional information becomes available, an additional report will be submitted.Device evaluated by manufacturer? remains implants, discarded.

Event Description

Tip of pin being used broke off and left in patient's distal femur.

Manufacturer Narrative

On (b)(6) 2019, a patient was undergoing a subchondroplasty procedure.The sales representative was able to speak about the events in the case.The sales representative stated that the doctor had used a mallet to hammer in the cannula, which had accufill in it at the time.The surgeon could not get the syringe to unload into the bone.Before the surgeon hit it, it would unload (the cannula) when he twisted the side perforated pin aiming it superior.The sales representative's assumption on why the surgeon used the mallet is that the surgeon was right on chondral bone inferiorly restricting the accufill from exiting the pin and when the surgeon spun the pin, there were no restrictions.They opened another cannula and inserted it.After turning the fenestrations, they were able to inject the accufill without any issue.While the scp was hardening and the accuport was in the patient, they were inspecting the knee with the scope to look for the potential extravasation of the accufill.The surgeon had mentioned that the stylus hadn¿t been fully seated while they were scoping.The cannula was removed and it was noted that it had broken at the fenestrations.It was unknown if the cannula was reversed in order to be removed.The surgeon chose to leave the broken fragment of the cannula in the patient.The surgery was successful and the patient is okay, despite the broken cannula.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.This technique has been reviewed with the sales representative.The product was not returned for the investigation.A picture was received of the placement of the accuport in the bone, but not 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.

Event Description

Tip of pin being used broke off and left in patient's distal femur.

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

Tip of pin being used broke off and left in patient's distal femur.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9409427
• MDR Text Key: 169020401
• Report Number: 3008812173-2019-00053
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Device Age: 17 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/05/2019
• 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: 62 YR
• Patient Weight: 90