MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN 3.2MM X 140MM STERILE 2 PACK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	213527
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: postoperative radiograph of makotka revealed a fractured tip of the 3.2mm x 140mm bone pin inserted into the femur, with the broken fragment remaining in place.As a corrective measure, the pin insertion site was reopened, the pin was removed, and the wound was closed.

• Brand Name: BONE PIN 3.2MM X 140MM STERILE 2 PACK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 24040930
• Report Number: 3005985723-2026-00017
• Device Sequence Number: 18426865
• Product Code: OLO
• UDI-Device Identifier: 07613327412376
• UDI-Public: 07613327412376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 213527
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown