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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
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 when additional information becomes available.H3 other text : not available.
Event or Problem Description
The femur bone pin was broken during surgery using mako system.The doctor made an incision with a scalpel to remove the broken pin from the patient's body.The bone pin was discarded immediately after removal and the surgery completed without problem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mako bone pins was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of the device history records cannot be conducted as the lot/serial number was not reported.-complaint history review: a complaint history review cannot be conducted as the lot/serial number was not reported.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
The femur bone pin was broken during surgery using mako system.The doctor made an incision with a scalpel to remove the broken pin from the patient's body.The bone pin was discarded immediately after removal and the surgery completed without problem.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18369994
• Report Number: 3005985723-2023-00186
• Device Sequence Number: 7834987
• Product Code: OLO
• UDI-Device Identifier: 07613327412376
• UDI-Public: 07613327412376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172301
• 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,Followup
• Report Date (Section B): 04/09/2024

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: 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: Not provided
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male