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

Model Number	112680
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
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
The bone pin stuck in the short array stabilizer, impossible to extract.Case type: tka, left side.
Event or Problem Description
The bone pin is stuck in the short array stabilizer, impossible to extract.Case type: tka, left side.
Additional 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 or Problem Description
The bone pin is stuck in the short array stabilizer, impossible to extract.Case type: tka, left side.
Additional 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9764840
• Report Number: 3005985723-2020-00114
• Device Sequence Number: 19534732
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 112680
• Device Catalogue Number: 112680
• Device Lot Number: 19410117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 04/13/2020; 05/06/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 05/01/2020; 05/07/2020
• 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: Hospitalization; Other