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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that total knee arthroplasty was performed with rosa knee.When fixed navi-tracker to the patient femoral bone with the pins, surgeon had a hard time to insert them because the patient bone quality was very good.When the surgeon removed them to re-insert, one of them broke at the tip.Subsequently, another pin was used to complete the procedure.Postoperatively, the broken tip was seen on x-ray.No revision is planned.No additional information.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: country: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Physical and technical evaluation was performed.The reported fractured tip of the pin was confirmed.Additionally two pictures provided also display the broken pin tip.Review of the dhr for p/n 20-8000-00-10, lot # 65443479 (cas fix pin 3.2d x 150mm str) did not identify any related deviations or anomalies which would have caused or contributed to the reported event.The root cause of the broken pin could not be determined precisely 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.

• 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; 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: 16005571
• Report Number: 0009617840-2022-00030
• Device Sequence Number: 6577890
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(17)270424(10)65443479
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/09/2023

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: 20-8000-000-10
• Device Lot Number: 65443479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2021
• 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