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 Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
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
3.2mm pin broke whilst placing in tibia during mako tka.No medical records or xrays available.Pin fully retrieved.
Additional Manufacturer Narrative
Reported event: 3.2mm pin broke whilst placing in tibia during mako tka.No medical records or xrays available.Pin fully retrieved.Product evaluation and results: as per the image provided the bone pin can be seen broken.Product history review: review of the device history records indicate 800 devices were manufactured and accepted into final stock on 04/11/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 143110, l/n w64081-2 shows no additional complaints related to the failure in this investigation.Conclusions: the defect can be confirmed from the image provided.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 there have been no nc and capa associated with the product and failure mode reported in this event.
Event or Problem Description
3.2mm pin broke whilst placing in tibia during mako tka.No medical records or xrays available.Pin fully retrieved.

• 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: 8932807
• Report Number: 3005985723-2019-00599
• Device Sequence Number: 2128003
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: W64081-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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
• Patient Age: 76 YR
• Patient Weight: 85