MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Model Number	143140
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
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
Small end piece of work one 3.2mm x 140mm bone bin found to be missing when pins removed from femur at completion of operation.Small piece remains in patient bone.Male patient undergoing l) tka.Piece of pin remains in patient.Will require x-ray to determine position and if any further action required.No surgical delay or effect on procedure.
Additional Manufacturer Narrative
Reported event: small end piece of work one 3.2mm x 140mm bone bin found to be missing when pins removed from femur at completion of operation.Small piece remains in patient bone.Male patient undergoing l) tka.Piece of pin remains in patient.Will require x-ray to determine position and if any further action required.No surgical delay or effect on procedure.Product evaluation and results: as per the visual inspection from the image provided in the communication log that the broken bone pin can be confirmed.Product history review: review of the product history records indicate (b)(4) were manufactured under lot no w65361-1 and were accepted into final stock on 04/26/2019.No non-conformance were identified during inspection.Complaint history review: review of complaints in catsweb and trackwise related to p/n 143140, lot number w65361-1 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could be confirmed via visual inspection of 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
Small end piece of work one 3.2mm x 140mm bone bin found to be missing when pins removed from femur at completion of operation.Small piece remains in patient bone.Male patient undergoing l) tka.Piece of pin remains in patient.Will require x-ray to determine position and if any further action required.No surgical delay or effect on procedure.

• Brand Name: BONE PIN, 3.2MM X 140MM, 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: 9378222
• Report Number: 3005985723-2019-00847
• Device Sequence Number: 19397651
• Product Code: OLO
• UDI-Device Identifier: 00848486018146
• UDI-Public: 00848486018146
• 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): 02/19/2020

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 Model Number: 143140
• Device Catalogue Number: 143140
• Device Lot Number: W65361-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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