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

Model Number	143110
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
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
Tibia pin broken off in patient tibia while trying to extract.It is believed pin was hit with keel punch when preparing tibia and thus created weak point.Pins were 3.2mm x 110mm mako consumables.Two packets of pins opened for bilateral case so not sure which lot number of broken pin.Image attached.Surgeon noted it was only small piece and no point removing.
Event or Problem Description
Tibia pin broken off in patient tibia while trying to extract.It is believed pin was hit with keel punch when preparing tibia and thus created weak point.Pins were 3.2mm x 110mm mako consumables.Two packets of pins opened for bilateral case so not sure which lot number of broken pin.Image attached.Surgeon noted it was only small piece and no point removing.
Additional Manufacturer Narrative
Reported event: tibia pin broken off in patient tibia while trying to extract.It is believed pin was hit with keel punch when preparing tibia and thus created weak point.Pins were 3.2mm x 110mm mako consumables.Two packets of pins opened for bilateral case so not sure which lot number of broken pin.Image attached.Surgeon noted it was only small piece and no point removing.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 05/16/2019.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 w64082-1 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint 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.

• 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: 9764600
• Report Number: 3005985723-2020-00110
• Device Sequence Number: 2806828
• 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): 04/22/2020

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: 143110
• Device Catalogue Number: 143110
• Device Lot Number: W64082-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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
• Patient Age: 66 YR
• Patient Weight: 115