MAUDE Adverse Event Report: ZIMMER CAS CAS FIXATION PIN 3.2D X 80MM STERILE; 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	01/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint : (b)(4).Additional information was made available on jan 26th 2022 that a fragmented part of the device was retained in the patients body.The event was reassessed and deemed reportable.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.Device was discarded onsite.
Event or Problem Description
It was reported that during a tka utilizing rosa knee instrumentation the tip of the fixation pin broke off upon insertion into the tibia.The component that broke off was retained in the patients tibia and was not removed.New pins were opened and the procedure was completed successfully.There was no additional patient impact reported and no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The broken pin could not be evaluated as it was not returned for investigation.Pictures of the broken pin or post-op x-rays were unable to be provided to confirm the reported events.Device history record review was unable to be performed as the lot number could not be identified.The definitive root cause could not be determined based on 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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: CAS FIXATION PIN 3.2D X 80MM STERILE
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13562081
• Report Number: 0009617840-2022-00010
• Device Sequence Number: 14567230
• Product Code: OLO
• UDI-Device Identifier: 00889024563636
• UDI-Public: (01)00889024563636
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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: 20800000011
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown