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

Catalog Number	112680
Medical Device Problem Codes	Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Sales rep reported that when inserting a 4x 110 pin ( lot w63530 code 114110) into pin stabiliser ( code 112680 lot 19050915) pin bent and snapped in stabiliser.System 6 was required to remove pin.New pin had to be used with new stabiliser.The procedure was a left mako unicompartmental knee replacement.There was a delay of 10 minutes.Case type: pka.Surgical delay: 10 minutes.
Event or Problem Description
Sales rep reported that when inserting a 4x 110 pin ( lot w63530 code 114110) into pin stabiliser ( code 112680 lot 19050915) pin bent and snapped in stabiliser.System 6 was required to remove pin.New pin had to be used with new stabiliser.The procedure was a left mako unicompartmental knee replacement.There was a delay of 10 minutes.Case type: pka.Surgical delay: 10 minutes.
Additional Manufacturer Narrative
Reported event: sales rep reported that when inserting a 4x 110 pin ( lot w63530 code 114110) into pin stabiliser ( code 112680 lot 19050915) pin bent and snapped in stabiliser.System 6 was required to remove pin.New pin had to be used with new stabiliser.The procedure was a left mako unicompartmental knee replacement.There was a delay of 10 minutes.Product evaluation and results: product inspection was not performed as product was not returned.Product history review: review of the device history records indicates 128 device(s) were manufactured and accepted into final stock on 12/08/2015.No non conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112680, lot 19050915 shows no additional complaint(s) related to the failure in this investigation.Conclusions: the part alleged is a concomitant part since the failure was due to the bone pin which got damaged during the assembly further leading to the damage of the array stabilizer.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 and capas associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.

• Brand Name: ARRAY STABILIZER, SHORT, 4.0MM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8952226
• Report Number: 3005985723-2019-00628
• Device Sequence Number: 11426508
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 112680
• Device Lot Number: 19050915
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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