MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2-PIN CLAMP- ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112270
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
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
During cutting for a tka made all cuts beside distal and posterior chamfer cut and the femoral array became visibly loose on the posterior chamfer cut.Surgeon and pa believe that the femoral array was properly tightened.Believe malfunction in 1/3 parts (femoral array, side clamp, pin clamp) or all parts.Requesting replacement for all 3 parts.Case was finished robotically and implants fit well.Case type: tka.Surgical delay: approx.16 - 30 minutes.
Additional Manufacturer Narrative
Reported event: it was reported that during cutting for a tka, made all cuts beside distal and posterior chamfer cut and the femoral array became visibly loose on the posterior chamfer cut.Surgeon and pa believe that the femoral array was properly tightened.They believe the malfunction in 1/3 parts (femoral array, side clamp, pin clamp) or all parts.Requesting replacement for all 3 parts.Case was finished robotically and implants fit well.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: review of the device history records indicate (b)(4) devices were manufactured under lot no 201743060802 and 200 were accepted into final stock on 06/07/2017, (b)(4) were accepted into final stock on 06/21/2017, and a further (b)(4) device was accepted into final stock on 06/21/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112270, lot 201743060802 shows no 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.Device not returned.
Event or Problem Description
During cutting for a tka made all cuts beside distal and posterior chamfer cut and the femoral array became visibly loose on the posterior chamfer cut.Surgeon and pa believe that the femoral array was properly tightened.Believe malfunction in 1/3 parts (femoral array, side clamp, pin clamp) or all parts.Requesting replacement for all 3 parts.Case was finished robotically and implants fit well.Case type: tka.Surgical delay: approx.16 - 30 minutes.

• Brand Name: 2-PIN CLAMP- ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8706989
• Report Number: 3005985723-2019-00432
• Device Sequence Number: 13951340
• Product Code: OLO
• UDI-Device Identifier: 00848486015909
• UDI-Public: 00848486015909
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 08/07/2019

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 Catalogue Number: 112270
• Device Lot Number: 201743060802
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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