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

Catalog Number	20-8000-000-11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: germany.Concomitant medical product: 20-8020-100-26-rosa recon platform.(serial# (b)(6)).Unknown stryker 8 machine-unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product was discarded by hospital.
Event or Problem Description
It was reported during an initial knee procedure, the surgeon placed the pins for the navitracker into the tibia.Subsequently, the 80mm pin broke off in the process.The pin was completely removed from the tibia.A competitor machine with quick-release fastener was used to place the pin.No patient harm or impact.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The pictures provided display the broken cas fix pin, confirming the reported event.Physical and technical evaluation was not performed as device was not available for evaluation.Review of the dhr identified no deviation and/or anomalies related to the reported complaint event.The root cause of the broken pin could not be determined with the information available.Possible contributing factors are excessive force and/or off-angle application during insertion/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: 16807332
• Report Number: 0009617840-2023-00005
• Device Sequence Number: 17687591
• Product Code: OLO
• UDI-Device Identifier: 00889024563636
• UDI-Public: (01)00889024563636(17)270131(10)65348996
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210121
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 20-8000-000-11
• Device Lot Number: 65348996
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Unknown