MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH; ORTHOPAEDIC BONE WIRE

Catalog Number	00223200418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Foreign Body Embolism (4439)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6b: explanted on unknown date in (b)(6) 2023.D10: cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot#64767779.Cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot# 64781160.Cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot# 64781160.Cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot# 64872651.Cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot# 64970958.Cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot# 65002935.Cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot# 65002935.Cable cerclage cable with crimp 1.8 mm dia.635 mm length cat#00223200418 lot# 65002935.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02523, 0001822565 - 2023 - 02524, 0001822565 - 2023 - 02525, 0001822565 - 2023 - 02526, 0001822565 - 2023 - 02527, 0001822565 - 2023 - 02528, 0001822565 - 2023 - 02529, 0001822565 - 2023 - 02530.
Event or Problem Description
It was reported that a patient underwent an additional procedure approximately 4 months post implantation due to cerclage cables occluding the superficial femoral artery.The cables were removed and the vessel was stented open.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h3, h6, h10 reported event was confirmed by review of radiographs.Review of the available records identified following: revision due to cerclage cable occluding superficial femoral artery removed cables and implemented stents.The patient now has complex regional pain syndrome in their left foot.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH
• Common Device Name: ORTHOPAEDIC BONE WIRE
• 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: 17740695
• Report Number: 0001822565-2023-02531
• Device Sequence Number: 20348627
• Product Code: KTT
• UDI-Device Identifier: 00889024039513
• UDI-Public: (01)00889024039513(17)310123(10)65002935
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/25/2024

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 Catalogue Number: 00223200418
• Device Lot Number: 65002935
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female