MAUDE Adverse Event Report: ZIMMER CAS CAS FIX PIN 3.2D X 80MM STR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2022

Event Type  Injury  

Event Description

It was reported that during a robotic assisted tka, a tibial pin for fixating the navigation tracker broke off.Due to this, the pin remained in the patients bone.There was no additional patient impact reported.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Foreign source : canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.X-rays were provided and reviewed by a health care professional.Review of the x-ray noted a punctate metallic focus in the region of surgical staples and leads which could represent a foreign body.No product was returned; visual and dimensional evaluations could not be performed.The dhr was reviewed for any deviations or anomalies that might have contributed to the reported event.No deviations were discovered; therefore, it is not expected that the manufacturing process contributed.A definitive root cause is unable to be determined with the information available.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.

• Brand Name: CAS FIX PIN 3.2D X 80MM STR
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15364179
• MDR Text Key: 299314939
• Report Number: 0009617840-2022-00025
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 0088902456363
• UDI-Public: (01)0088902456363(17)260830(10)65107616
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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: 20-8000-000-11
• Device Lot Number: 65107616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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