MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5° CAPTURED LEFT MEDIAL TIBIAL CUT GUIDE DO NOT IMPLANT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: switzerland.Concomitant medical products: product id: 00590102000, product type: headless trocar drill pin 3.2 mm diameter 75 mm length, lot: 65403154.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
It was reported that when fixing the relevant tibial cutting block with the pin, metal debris formed.There was no surgical delay.The surgical technique was utilized.The surgery was not completed with a second device.The metal debris did fall into the patient and staff were not sure if all of the pieces had been retrieved.No post-op imaging was taken to confirm if metal debris were retained.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as no serious injury or harm to the patient was reported for this event or prior events with same or similar products.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 available at the time of this report.

• Brand Name: 5° CAPTURED LEFT MEDIAL TIBIAL CUT GUIDE DO NOT IMPLANT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16310917
• Report Number: 0001822565-2023-00309
• Device Sequence Number: 15154275
• Product Code: HSX
• UDI-Device Identifier: 00880304809086
• UDI-Public: (01)00880304809086(10)63735849
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200151
• 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): 07/11/2023

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 Model Number: N/A
• Device Catalogue Number: 42539905185
• Device Lot Number: 63735849
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2017
• 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: Reuse
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Female