MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 4MM X 140MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	144140
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
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
Surgeon was removing femoral pins after completing mako portion of the total knee replacement and the femoral distal pin snapped while being pulled out.Case type: tka.Surgical delay: =15 minutes.Did the event occur during the case? as per the mps: yes, the event occurred during the case.We had just opened final implants but had not impacted yet.Was the patient under anesthesia? yes.Were any debris/components left inside of the patient? (yes/no) as per the mps: yes, a piece of the pin was left inside the bone.The surgery was paused and an x-ray was taken.The surgeon decided to leave the piece of pin inside of the patient.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: it was reported that surgeon was removing femoral pins after completing mako portion of the total knee replacement and the femoral distal pin snapped while being pulled out.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no w59991-1 and were accepted into final stock on 02/21/2019.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 144140 , lot number w59991-1, shows no additional complaints related to the failure in this investigation.Conclusion: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
Surgeon was removing femoral pins after completing mako portion of the total knee replacement and the femoral distal pin snapped while being pulled out.Case type: tka.Surgical delay: =15 minutes.Did the event occur during the case? as per the mps: yes, the event occurred during the case.We had just opened final implants but had not impacted yet.Was the patient under anesthesia? yes.Were any debris/components left inside of the patient? (yes/no) as per the mps: yes, a piece of the pin was left inside the bone.The surgery was paused and an x-ray was taken.The surgeon decided to leave the piece of pin inside of the patient.

• Brand Name: BONE PIN, 4MM 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: 8540296
• Report Number: 3005985723-2019-00309
• Device Sequence Number: 1744619
• Product Code: OLO
• UDI-Device Identifier: 00848486018177
• UDI-Public: 00848486018177
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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 Catalogue Number: 144140
• Device Lot Number: W59991-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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
• Patient Age: 75 YR