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 Code	Foreign Body In Patient (2687)
Date of Event	05/16/2022
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.Device not returned.
Event or Problem Description
The 3.2 x 140 pins used to place the femoral array, when being removed with a drill, one pin broke off in the femur.The pa removing pin did not catch that it was broken and patient was sent to pacu where a post op x-ray detected the half broken off.Patient was brought back and the remaining pin was removed.
Event or Problem Description
The 3.2 x 140 pins used to place the femoral array, when being removed with a drill, one pin broke off in the femur.The pa removing pin did not catch that it was broken and patient was sent to pacu where a post op x-ray detected the half broken off.Patient was brought back and the remaining pin was removed.
Additional Manufacturer Narrative
Reported event.An event regarding crack/fracture involving a mako bone pins was reported.The event was not confirmed because the product was not available for inspection.Method & results.Product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device history records cannot be conducted as the lot/serial number was not reported.Complaint history review: a complaint history review cannot be conducted as the lot/serial number was not reported.Conclusions: the alleged failure mode was not confirmed because 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.H3 other text : device not returned.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: perla zima ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 14675020
• Report Number: 3005985723-2022-00075
• Device Sequence Number: 17495364
• Product Code: OLO
• UDI-Device Identifier: 00848486018146
• UDI-Public: 00848486018146
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/29/2022

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 Model Number: 143140
• Device Catalogue Number: 143140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female