MAUDE Adverse Event Report: ZIMMER CAS CAS FIX FLUTED 3.2 DIA X 150; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source foreign country: germany.An investigation into this incident is currently underway.Once the investigation has been completed and the results are made available, a follow up mdr will be submitted.Part of device remains in patient.

Event Description

It was reported that the tip of the pin, which is used to attach the femoral navitracker, remained in the patient's femur.Attempts are being made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via x-ray images provided and reviewed by a health care professional.Review confirmed the presence of a nonspecific triangular-shaped hypodense structure in the bone.No contributing factors from the bone were detected.Dhr review could not be performed as the serial and/or lot numbers for the product could not be identified.The definitive root cause could not be determined based on the information available.Potential contributing factors may include excessive force applied during insertion or removal.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device was discarded.

Event Description

No additional information on the reported event.

• Brand Name: CAS FIX FLUTED 3.2 DIA X 150
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 15674935
• MDR Text Key: 302436584
• Report Number: 0009617840-2022-00026
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8000-000-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other