MAUDE Adverse Event Report: ZIMMER TMT CAS FIX PIN 3.2D X 150MM STR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report supersedes previous reports sent: (b)(4).The device is used for treatment.Technical review and physical evaluation no product was returned or pictures of the device provided; visual and dimensional evaluations could not be performed.Complaint history review a complaint history review was conducted for part numbers ¿20-8000-000-10¿ and ¿20800000010¿ from 08 june 2022 to present.The search identified no additional similar complaints for the same lot number.The search identified no additional similar complaints reported for the part number.Recall assessment: there are no previous recalls associated to the part numbers ¿20-8000-000-10¿.Root cause: after review with health care professionals (see (b)(4)) regarding standards of care and the warnings included in the rosa user manual and surgical technique, the root cause of the reported issue is attributed to use error.Complaints are monitored through monthly complaint review in order to trend the issues and discuss them during the monthly capa feeder process.Any spike or unfavorable trend will be reviewed for further action per (b)(4).
Event or Problem Description
It was reported that a patient experienced a partial artery rupture and subsequent bleeding during a tka after the surgeon inserted the spacer into extension.The procedure was delayed by 120 minutes for vascular intervention.Attempts have been made and no further event information is available at the time of this report.

• Brand Name: CAS FIX PIN 3.2D X 150MM STR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17697957
• Report Number: 3005751028-2023-00005
• Device Sequence Number: 17989503
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(11)221003(10)65630392
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/07/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8000-000-10
• Device Lot Number: 65630392
• 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: 08/11/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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: 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