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

Model Number	143140
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	01/27/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
In tka surgery using mako, to place the femoral array on the femur, drilled the bone pin.It goes through the anterior cortex and reaches the opposite cortex.The tip of the pin was broken, and the tip was embedded in the bone.At the doctor's discretion, another pin was used to place the pin at another location, and the operation was completed.However, after the operation, an x-ray was taken and confirmed the broken tip has remained in the bone.Since remained inside the bone, the operation has been completed without removing it.
Event or Problem Description
In tka surgery using mako, to place the femoral array on the femur, drilled the bone pin.It goes through the anterior cortex and reaches the opposite cortex.The tip of the pin was broken, and the tip was embedded in the bone.At the doctor's discretion, another pin was used to place the pin at another location, and the operation was completed.H owever, after the operation, an x-ray was taken and confirmed the broken tip has remained in the bone.Since remained inside the bone, the operation has been completed without removing it.
Additional Manufacturer Narrative
Update to b2.Reported event: in tka surgery using mako, to place the femoral array on the femur, drilled the bone pin.It goes through the anterior cortex and reaches the opposite cortex.The tip of the pin was broken, and the tip was embedded in the bone.At the doctor's discretion, another pin was used to place the pin at another location, and the operation was completed.However, after the operation, an x-ray was taken and confirmed the broken tip has remained in the bone.Since remained inside the bone, the operation has been completed without removing it.Product inspection: as per the visual inspection from the image provided in the communication log that the broken bone pin can be confirmed.Product history review: review of the product history records indicate 1022 devices were manufactured under lot no lot w51416-1 and accepted into final stock on 04/17/2017.No non-conformances were identified during inspection.Complaint history review: review of complaints in catsweb and trackwise related to p/n 143140, lot number w51416 shows no additional complaints related to the failure in this investigation.Conclusion: the event was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

• Brand Name: BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9749619
• Report Number: 3005985723-2020-00097
• Device Sequence Number: 16915728
• Product Code: OLO
• UDI-Device Identifier: 00848486018146
• UDI-Public: 00848486018146
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 143140
• Device Catalogue Number: 143140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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: Hospitalization; Other