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

Model Number	143110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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.
Event or Problem Description
During the tka operation using mako, drilled the bone pin to the femoral shaft to place the femoral array.The tip of the pin broke when it reached the second cortex.Replaced with another pin, but it also broke.The third pin could be placed, and operation was completed.However, after operation, x-ray confirmed three broken piece remained in the patient bone.Those could not be removed, so those were left and operation was finished.
Event or Problem Description
During the tka operation using mako, drilled the bone pin to the femoral shaft to place the femoral array.The tip of the pin broke when it reached the second cortex.Replaced with another pin, but it also broke.The third pin could be placed, and operation was completed.However, after operation, x-ray confirmed three broken piece remained in the patient bone.Those could not be removed, so those were left and operation was finished.
Additional Manufacturer Narrative
Update to d2.Reported event: during the tka operation using mako, drilled the bone pin to the femoral shaft to place the femoral array.The tip of the pin broke when it reached the second cortex.Replaced with another pin, but it also broke.The third pin could be placed, and operation was completed.However, after operation, x-ray confirmed three broken piece remained in the patient bone.Those could not be removed, so those were left and operation was finished.Product evaluation and results: visual inspection did not confirms the broken tip of the bone pin.Product history review: review of the device history records indicate 249 devices were manufactured and accepted into final stock on (b)(6) 2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 143110, l/n w66568 shows no additional complaints related to the failure in this investigation.Conclusions: the failure of the broken bone pin from the tip cannot be confirmed via inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: BONE PIN, 3.2MM X 110MM, STERILE 2 PACK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9758000
• Report Number: 3005985723-2020-00105
• Device Sequence Number: 2806826
• Product Code: OLO
• UDI-Device Identifier: 00848486018139
• UDI-Public: 00848486018139
• Combination Product (Y/N): N
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 143110
• Device Catalogue Number: 143110
• Device Lot Number: W66568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other