MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 4MM X 110MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Model Number	144110
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	11/13/2019
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
The surgeon began to manually ream the tibia for a universal baseplate with pressfit stem, when removing the tibial bone pins for the array assembly one of the bone pins broke inside the patient.Using x-ray the surgeon was able to locate the bone pin fixed inside cortical bone and was unable to retrieve it.Case type: tka.Surgical delay: 15 minutes.
Additional Manufacturer Narrative
Reported event: the surgeon began to manually ream the tibia for a universal baseplate with pressfit stem, when removing the tibial bone pins for the array assembly one of the bone pins broke inside the patient.Using x-ray the surgeon was able to locate the bone pin fixed inside cortical bone and was unable to retrieve it.Product evaluation and results: product inspection could not be performed as the product was not returned for evaluation.Product history review: review of the device history records for l/n w64539-1 indicate 969 devices were manufactured and accepted into final stock on 08/05/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 144110, lot number w64539-1, shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as 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.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.H3 other text : device not returned.
Event or Problem Description
The surgeon began to manually ream the tibia for a universal baseplate with pressfit stem, when removing the tibial bone pins for the array assembly one of the bone pins broke inside the patient.Using x-ray the surgeon was able to locate the bone pin fixed inside cortical bone and was unable to retrieve it.Case type: tka.Surgical delay: = 15 minutes.

• Brand Name: BONE PIN, 4MM X 110MM, 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: 9453219
• Report Number: 3005985723-2019-00901
• Device Sequence Number: 3090673
• Product Code: OLO
• UDI-Device Identifier: 00848486018160
• UDI-Public: 00848486018160
• Combination Product (Y/N): N
• 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): 02/25/2020

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: 144110
• Device Catalogue Number: 144110
• Device Lot Number: W64539-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/25/2020
• 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