MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 110MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	143110
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	06/13/2019
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
143110 mako 3.2mm x110mm pin snapped.Some of the pin is inside the patient tibia.
Event or Problem Description
143110 mako 3.2mm x110mm pin snapped.Some of the pin is inside the patient tibia.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections.Reported event: it was reported that "143110 mako 3.2mm x110mm pin snapped.Some of the pin is inside the patient tibia." the event was not confirmed.Method & results: device evaluation and results: not performed as no items were returned.Product history review: not performed as no lot number was reported.Complaint history review: not performed as no lot number was reported.Conclusion: the exact cause of the event could not be determined because the product was not received.A review of stryker¿s nc/capa database indicated that there have been 01 nc(s) and 01 capa(s) associated with the product and failure mode reported in this event.These include nc#: 1470754 and capa#: 1480798.Corrective action/preventive action: no action is required at this time as there is no confirmed failure mode.H3 other text : product was not available for evaluation.

• Brand Name: BONE PIN, 3.2MM 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: 8743610
• Report Number: 3005985723-2019-00472
• Device Sequence Number: 1330142
• Product Code: OLO
• UDI-Device Identifier: 00848486018139
• UDI-Public: 00848486018139
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/04/2019

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: 143110
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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