MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA; CERCLAGE, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that during the mmi report, it was found that the cerclage cable has fractured.The fractured cable was removed during the revision procedure.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Report source: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d9, g3, g6, h1, h2, h3, h6, h10.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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA
• Type of Device: CERCLAGE, FIXATION
• 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: 16731299
• MDR Text Key: 313199475
• Report Number: 0001822565-2023-01022
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 00889024039513
• UDI-Public: (01)00889024039513(17)311103(10)65240153
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00223200418
• Device Lot Number: 65240153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female