MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE-READY CABLE GRIP SYSTEM CERCLAGE CABLE WITH NEEDLE AND CRIMPS; CERCLAGE, FIXATION

Catalog Number	00223202113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgery for a patellar fracture with a cable system.Approximately 10 days post-implantation, the patient experienced pain and radiographic evaluation showed the cable was broken.Approximately 1 day later, the patient underwent revision surgery.The patient underwent revision; no additional postoperative details were provided.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).E1: (b)(6).E1: phone number - (b)(6).G2: foreign - event occurred in china.The 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.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b3; b4; b5; b6; d2; d6; d9; g1; g3; g4; g6; h1; h2; h3; h6.Corrections to b3 and d6.The reported event was confirmed by review of x-rays.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: pin-and-cable fixation of a displaced transverse olecranon fracture.There is loss of fracture fixation with migration of one of the pins and fracture of the cable.The wire, needle, and leader were not returned.It is unknown whether or not all of the cable has been returned.Sem analysis identified that most wires showed significant smearing and possible biological debris.On two wires, fracture surface artifacts of ductile dimples were observed in unsmeared regions.Fracture surface artifacts of ductile dimples are consistent with the overload failure mode; however, the initiation failure mode cannot be determined with certainty due to the excessive smearing on all observed wires.The device history record was reviewed, and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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-READY CABLE GRIP SYSTEM CERCLAGE CABLE WITH NEEDLE AND CRIMPS
• Common Device Name: 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: 23638867
• Report Number: 0001822565-2025-04282
• Device Sequence Number: 9805553
• Product Code: JDQ
• UDI-Device Identifier: 00889024039612
• UDI-Public: (01)00889024039612(17)350517(10)67325016
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00223202113
• Device Lot Number: 67325016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown