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

Catalog Number	143140
Medical Device Problem Codes	Use of Device Problem (1670); Non Reproducible Results (4029)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
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
Patient experienced fracture at femoral pin site post op.The pin was removed and discarded after the case.A few weeks after the case, the patient¿s femur fractured where the pin was.The pin is not available for return because it was discarded after the case.Case type: tka.
Event or Problem Description
Patient experienced fracture at femoral pin site post op the pin was removed and discarded after the case.A few weeks after the case, the patient¿s femur fractured where the pin was.The pin is not available for return because it was discarded after the case.Case type: tka.
Additional Manufacturer Narrative
Reported event: patient experienced fracture at femoral pin site post op the pin was removed and discarded after the case.A few weeks after the case, the patient¿s femur fractured where the pin was.The pin is not available for return because it was discarded after the case.Case type: tka.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the product history records indicate 440 devices were manufactured under lot no w51426-2 and were accepted into final stock on 08/11/2017.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 143140, lot number w51426-2 shows no additional complaints 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 no nc and capa associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.

• 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: 8306999
• Report Number: 3005985723-2019-00097
• Device Sequence Number: 19248334
• Product Code: OLO
• UDI-Device Identifier: 00848486018146
• UDI-Public: 00848486018146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 143140
• Device Lot Number: W51426-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 11/03/2019
• 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: Other; Required Intervention
• Patient Age: 51 YR