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

Model Number 143140

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2022

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 293928905
• Report Number: 3005985723-2022-00075
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female