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

Model Number	144110
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Foreign Body In Patient (2687)
Date of Event	01/27/2020
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 supplement al report will be submitted when additional information becomes available.
Event or Problem Description
When trying to remove the bone pins from the patient at the end of the procedure the tibial bone broke.Fluro was called into room to reveal that the bone pin was hit and bent during while performing the tibial keel punch.The surgeon opted to leave the broken pin in the patient.Case type: tka.Surgical delay= 15 minutes.
Event or Problem Description
When trying to remove the bone pins from the patient at the end of the procedure the tibial bone broke.Fluro was called into room to reveal that the bone pin was hit and bent during while performing the tibial keel punch.The surgeon opted to leave the broken pin in the patient.Case type: tka surgical delay15 minutes.
Additional Manufacturer Narrative
Reported event: when trying to remove the bone pins from the patient at the end of the procedure the tibial bone broke.Fluro was called into room to reveal that the bone pin was hit and bent during while performing the tibial keel punch.The surgeon opted to leave the broken pin in the patient.Case type: tka, surgical delay<= 15 minutes 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 cannot be conducted as the lot number is not provided.Complaint history review: review of the complaint history records cannot be conducted as the lot number is not provided.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.

• 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: 9750249
• Report Number: 3005985723-2020-00101
• Device Sequence Number: 3188777
• Product Code: OLO
• UDI-Device Identifier: 00848486018160
• UDI-Public: 00848486018160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/22/2020

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: No Information
• Device Model Number: 144110
• Device Catalogue Number: 144110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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