MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN-4MM X 170MM-STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	144170
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	06/17/2019
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
Post op when dr.(b)(6) was trying to remove the last 4 x 170 bone pin from the femur the bone pin broke off in the patient.We have not seen this before and wanted to bring awareness to the issue from today.Case type: tka.
Additional Manufacturer Narrative
Reported event: it was reported that post op when dr.(b)(6) was trying to remove the last 4 x 170 bone pin from the femur the bone pin broke off in the patient.We have not seen this before and wanted to bring awareness to the issue from.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: product history review could not be performed as lot was unknown.Complaint history review: complaint history review could not be performed as lot was unknown.Conclusions: 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: a review of stryker¿s nc/capa database indicated that there have been no nc¿s associated with the product and failure mode reported in this event.H3 other text : device not returned.
Event or Problem Description
Post op when dr.(b)(4) was trying to remove the last 4 x 170 bone pin from the femur the bone pin broke off in the patient.We have not seen this before and wanted to bring awareness to the issue from today.Case type: tka.

• Brand Name: BONE PIN-4MM X 170MM-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: 8748206
• Report Number: 3005985723-2019-00473
• Device Sequence Number: 16653773
• Product Code: OLO
• UDI-Device Identifier: 00848486018184
• UDI-Public: 00848486018184
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/09/2019

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: 144170
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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