MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN 3.2MM X 110MM STERILE 2 PACK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	213524
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Bone Notching (4890)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the mako bone pin 3.2mm×110mm broke while it was being inserted into the tibia and remained inside the bone.It was possible to remove it by excavating around the remained pin using a chisel and k-wire.A defect was created in the anterior cortical bone of the tibia, and the surgery time was extended by 10 minutes.
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a mako bone pins was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection confirmed the event.Device is broken at the tip angle.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
While reviewing the complaint record associated with this report, it was discovered that this event was incorrectly filed as a serious injury.We confirmed that this event did not cause or contribute to any life-threatening condition or permanent impairment to the patient and did not require any medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additionally, a review of complaint history records from january 1, 2015, until today, confirmed that there have been no reports of death or serious injury associated with similar events for this device family.Finally, the device¿s associated risk documentation confirmed that the highest potential severity of harm for this hazardous situation is a (s3/o2).Therefore, we will no longer be filing reports for this event type.

• Brand Name: BONE PIN 3.2MM X 110MM 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: 21539975
• Report Number: 3005985723-2025-00088
• Device Sequence Number: 15237280
• Product Code: OLO
• UDI-Device Identifier: 07613327412369
• UDI-Public: 07613327412369
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: Health Professional
• Device Catalogue Number: 213524
• Device Lot Number: 48GB0524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 10/29/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 07/14/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 76 KG