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

Catalog Number	213524
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	11/07/2018
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
Pin (213524) tip broke off in tibia upon insertion.Surgeon attempted to put pin in tibial crest of male patient with dense bone (according to surgeon).Case type: pka.Post x-ray attached.
Event or Problem Description
Pin (213524) tip broke off in tibia upon insertion.Surgeon attempted to put pin in tibial crest of male patient with dense bone (according to surgeon).Case type: pka.Post x-ray.
Additional Manufacturer Narrative
Reported event: pin (213524) tip broke off in tibia upon insertion.Surgeon attempted to put pin in tibial crest of male patient with dense bone (according to surgeon).Case type: pka , post x-ray.Product evaluation and results: the product was unavailable for inspection as the product was not returned.The post op x-ray provided shows a radiopaque object in the typical location and similar size for the bone pin tip.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 48011117 and accepted on 12-21-17.Review of the product history records indicate (b)(4) devices were manufactured under lot no 48011117 and accepted on 12-22-17.Review of the product history records indicate (b)(4) devices were manufactured under lot no 48011117 and accepted on 12-22-17.Complaint history review: a review of complaints in trackwise related to p/n 213524, l/n 48011117 shows no additional complaints under investigation related to the failure in this investigation.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 there have been an ncs 1470754 and capa 1480798 are associated with the product and failure mode reported in this event.

• 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: 8125796
• Report Number: 3005985723-2018-00699
• Device Sequence Number: 13883488
• Product Code: OLO
• UDI-Device Identifier: 07613327412369
• UDI-Public: 07613327412369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 02/08/2019

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: 213524
• Device Lot Number: 48011117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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