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

Model Number 112680

Device Problems Difficult to Remove (1528); Separation Failure (2547); Physical Resistance/Sticking (4012)

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

Event Date 02/05/2020

Event Type  malfunction  

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 Description

The bone pin stuck in the short array stabilizer, impossible to extract.Case type: tka, left side.

Event Description

The bone pin is stuck in the short array stabilizer, impossible to extract.Case type: tka, left side.

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.

Event Description

The bone pin is stuck in the short array stabilizer, impossible to extract.Case type: tka, left side.

Manufacturer Narrative

Reported event: the bone pin is stuck in the short array stabilizer, impossible to extract.Product evaluation and results: product inspection was not performed as product was not available for inspection.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 19410117 and accepted into final stock on 05/23/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112680, l/n 19410117 shows 05 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.Device not returned.

• Brand Name: ARRAY STABILIZER, SHORT, 4.0MM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9764840
• MDR Text Key: 181556621
• Report Number: 3005985723-2020-00114
• 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: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2020

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
• Device Operator: Health Professional
• Device Model Number: 112680
• Device Catalogue Number: 112680
• Device Lot Number: 19410117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 04/13/2020; 05/06/2020
• Supplement Dates FDA Received: 05/01/2020; 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other