MAUDE Adverse Event Report: ZIMMER CAS CAS FIX PIN 3.2D X 150MM 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	01/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported that during a tka surgery using rosa instrumentation, the femoral pin cracked while drilling and part of the pin was lost in the patient's femur.New pins were opened and the procedure continued.After the procedure, an x-ray was taken and the surgeon decided to leave the fragment inside the patient.There was no additional patient impact reported.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported that during a tka surgery using rosa instrumentation, the femoral pin cracked while drilling and part of the pin was lost in the patient's femur.New pins were opened and the procedure continued.After the procedure, an x-ray was taken and the surgeon decided to leave the fragment inside the patient.There was no additional patient impact reported.It was reported that no further information is available.
Event or Problem Description
It was reported that during a tka surgery using robotic assisted technology, the femoral pin cracked while drilling and part of the pin was lost in the patient's femur.New pins were opened and the procedure continued.After the procedure, an x-ray was taken and the surgeon decided to leave the fragment inside the patient.There was no additional patient impact reported.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The subject device was returned for evaluation.Technical and visual inspection was performed per ¿sme subject matter expert¿ and visual inspection confirmed the broken end of the pin.Review of the dhr identified no deviation or anomalies related to the reported complaint event.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CAS FIX PIN 3.2D X 150MM STR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13388686
• Report Number: 0009617840-2022-00006
• Device Sequence Number: 4858050
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(17)260715(10)65095647
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2022

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 Expiration Date: 07/15/2026
• Device Model Number: N/A
• Device Catalogue Number: 20-8000-000-10
• Device Lot Number: 65095647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 02/22/2022; 08/23/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/09/2022; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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 Sex: Male