MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 80MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	143080
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	07/10/2018
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
The tip of the 3.2x80mm bone pin was not intact when the surgeon removed the pin from the patient's tibia.Case type: pka.Was there a surgical delay? yes - =15 minutes.
Additional Manufacturer Narrative
It was reported that the tip of the 3.2x80mm bone pin was not intact when the surgeon removed the pin from the patient's tibia.No device inspection could be completed as the product was not available for evaluation.Nc 1694916 has been initiated in regards to missing product.Review of the product history records indicate 306 devices were manufactured under lot no w45250-3 and accepted into final stock on 09/01/2016.No non-conformances were identified during inspection.A review of complaints in catsweb and trackwise related to p/n 143080, lot number w45250-3 shows no additional complaints related to the failure in this investigation.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 re-opened.A review of stryker¿s nc/capa database indicated there have been 01 ncs 1470754 and capas 1480798 are associated with the product and failure mode reported in this event.
Event or Problem Description
The tip of the 3.2x80mm bone pin was not intact when the surgeon removed the pin from the patient's tibia.Case type: pka.Was there a surgical delay?.Yes - =15 minutes.

• Brand Name: BONE PIN, 3.2MM X 80MM, 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: 7685494
• Report Number: 3005985723-2018-00418
• Device Sequence Number: 683955
• Product Code: OLO
• UDI-Device Identifier: 00848486018122
• UDI-Public: 00848486018122
• 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): 12/05/2018

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: 143080
• Device Lot Number: W45250-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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