MAUDE Adverse Event Report: ZIMMER CAS ROSA SHOULDER HUMERAL REF; ROBOTICS, INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported the rosa humeral clamp created a hole through the cortical bone, and caused a fracture while implanting the stem.Fracture of the humerus needed cerclage wire around final implant.Additional information has been requested, however none is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The device was not returned to product surveillance for evaluation.No surgery logs were available for review.The picture provided displays the device itself, the part number and serial number and minor scuffs.The root cause of the reported event cannot be determined with 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 further event information is available at the time of this report.

• Brand Name: ROSA SHOULDER HUMERAL REF
• Common Device Name: ROBOTICS, INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec
• 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: 19392133
• Report Number: 0009617840-2024-00010
• Device Sequence Number: 15403728
• Product Code: OLO
• UDI-Device Identifier: 00887868558153
• UDI-Public: (01)00887868558153(10)W230473
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20808740000
• Device Lot Number: W230473
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose