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

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during tka using robotic assisted instrumentation, a pin snapped within the patient.Proper surgical technique was used when inserting the pins into the tibia.First pin was place proximally and second pin distal to that.The distal pin went through the near cortex fine and proceeded to 'stop' progressing into the bone.When the surgeon attempted to back the pin out and inspect what occurred.He noticed that the pin was broken.It was noted that the patient did not have unusually dense bone nor weak bone.This event occurred at the time of placing the trackers prior to registration.There was a 30-45 minute delay in procedure.Additional skin incision and pin required.The surgeon attempted to remove the pin intra-operatively but was unable to do so as the pin anchored into posterior cortical bone.No known impact to the patient, at this time the pin remains implanted in patient.Attempts for additional information have been made and no further information has been provided.
Additional Manufacturer Narrative
Zimmer biomet complaint:(b)(4).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.Fragmented pin is still in patient.
Additional Manufacturer Narrative
The fractured screw was unable to be returned to the product surveillance team as it was discarded by the site.Post-operative x-rays were provided of the patient's knee and reviewed by a subject matter expert (sme).The sme confirmed that a small metallic fragment was retained in the knee following the operation.The lot number was reviewed for any deviations and/or anomalies in the manufacturing process that may have contributed to this reported event.No deviations or anomalies were discovered; therefore, it is not expected that the manufacturing process contributed to the reported issue.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.
Event or Problem Description
No additional information on the reported event.

• Brand Name: CAS FIX PIN 3.2D X 80MM STR
• Common Device Name: 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: 14498905
• Report Number: 0009617840-2022-00023
• Device Sequence Number: 5579299
• Product Code: OLO
• UDI-Device Identifier: 00889024563636
• UDI-Public: (01)00889024563636(17)270119(10)65221983
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8000-000-11
• Device Lot Number: 65221983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: 59 YR
• Patient Sex: Male