MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY STABILIZER, SHORT, 4.0MM; STEREOTAXIC DEVICE, ROBOTICS

Model Number 112680

Device Problems Difficult to Remove (1528); Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2020

Event Type  malfunction  

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 Description

The customer reported that the 110mm x4mm tibial bone pin became stuck in the 4mm bone pin stabiliser.When trying to remove the pin from the patient at the end of surgery the pins thread was lost so the drill was unable to remove and it became wedged in the stabiliser.This resulted in two addition manual kits being opened in order to access tools to enable the surgeon to remove the pin.This was done with no harmful consequences to the patient although did delay the surgery slightly.Update: no unintended metal debris from the threads fell into the patient.

Manufacturer Narrative

While reviewing the complaint record associated with this report, it was discovered that this event was incorrectly filed as a serious injury.We confirmed that this event did not cause or contribute to any life-threatening condition or permanent impairment to the patient and did not require any medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additionally, a review of complaint history records from january 1, 2016 until today, confirmed that there have been no reports of death or serious injury associated with similar events for this device family.Finally, the device¿s associated risk documentation confirmed that the highest potential severity of harm for this hazardous situation is a s2.Therefore, we will no longer be filing reports for this event type.

Event Description

The customer reported that the 110mm x4mm tibial bone pin became stuck in the 4mm bone pin stabiliser.When trying to remove the pin from the patient at the end of surgery the pins thread was lost so the drill was unable to remove and it became wedged in the stabiliser.This resulted in two addition manual kits being opened in order to access tools to enable the surgeon to remove the pin.This was done with no harmful consequences to the patient although did delay the surgery slightly.**update** no unintended metal debris from the threads fell into the patient.

Event Description

The customer reported that the 110mm x4mm tibial bone pin became stuck in the 4mm bone pin stabiliser.When trying to remove the pin from the patient at the end of surgery the pins thread was lost so the drill was unable to remove and it became wedged in the stabiliser.This resulted in two addition manual kits being opened in order to access tools to enable the surgeon to remove the pin.This was done with no harmful consequences to the patient although did delay the surgery slightly.Update: no unintended metal debris from the threads fell into the patient.

Manufacturer Narrative

Reported event: the customer reported that the 110mm x4mm tibial bone pin became stuck in the 4mm bone pin stabilizer.When trying to remove the pin from the patient at the end of surgery the pins thread was lost so the drill was unable to remove and it became wedged in the stabilizer.This resulted in two addition manual kits being opened in order to access tools to enable the surgeon to remove the pin.This was done with no harmful consequences to the patient although did delay the surgery slightly.**update** no unintended metal debris from the threads fell into the patient.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 19550617 and accepted into final stock on 11/01/2017.No non-conformances were identified during inspection complaint history review: a review of complaints in catsweb and trackwise related to p/n 112680, lot number 19550617 shows one additional complaints related to the failure in this investigation, pr # (b)(4).Conclusion: 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: ARRAY STABILIZER, SHORT, 4.0MM
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9636406
• MDR Text Key: 176583679
• Report Number: 3005985723-2020-00054
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 112680
• Device Catalogue Number: 112680
• Device Lot Number: 19550617
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other