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

Catalog Number	210040
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
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
While attaching the stryker leg positioner clamp to the bed rail, 2 pieces of the clamp broke off and we were unable to repair or use the instrument.We were able to retrieve the broken pieces.This was the second clamp this happened to in the same case.Reference (b)(4) for 1st event.Case type: tka.Surgical delay: =15 minutes was the patient under anesthesia? "yes patient was under anesthesia but the procedure had not started yet".Did the leg fall off the table? "yes he was attempting to attach the clamp to the bed rail but there was no impact to the patients leg or anything on the patient at all".
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: -customer reported that while attaching the stryker leg positioner clamp to the bed rail, 2 pieces of the clamp broke off and we were unable to repair or use the instrument.Device evaluation and results: -device evaluation was not performed and the rail clamp assembly event was confirmed.Device history review: -review of the device history records indicate 50 devices were manufactured and inspected on 03-31-2017, they were accepted with no reported discrepancies.Complaint history review: -based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the rail clamp assembly.There has been 10 other events for the referenced lot number.Prs # 1579488, 1716880, 1802085, 1845671, 1856633, 1868102, 1909890, 1952517, 1963210 and 2080314 - were found to be from the same lot as the part in this complaint.The parts from these prs displayed the same failure.Conclusions: -from the image provided: the rail clamp assembly showed a broken 210042 (rail clamp lower) part, which is a component of the 210040 rail clamp assembly.Over torqueing of the clamp screw cause the part to break.Corrective action/preventive action: -as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.
Event or Problem Description
While attaching the stryker leg positioner clamp to the bed rail, 2 pieces of the clamp broke off and we were unable to repair or use the instrument.We were able to retrieve the broken pieces.This was the second clamp this happened to in the same case.Reference (b)(4) for 1st event.Case type: tka surgical delay: =15 minutes 1.Was the patient under anesthesia? "yes patient was under anesthesia but the procedure had not started yet".2.Did the leg fall off the table? "yes he was attempting to attach the clamp to the bed rail but there was no impact to the patients leg or anything on the patient at all".

• Brand Name: RAIL CLAMP ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8632859
• Report Number: 3005985723-2019-00369
• Device Sequence Number: 1643789
• Product Code: OLO
• UDI-Device Identifier: 00848486031831
• UDI-Public: 00848486031831
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 08/13/2019

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: 210040
• Device Lot Number: 19550816
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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