MAUDE Adverse Event Report: MAKO SURGICAL CORP. STRAIGHT CUP REAMER HANDLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	207084
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
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
Surgeon just started reaming the acetabulum with straight reamer handle.Proximal end tip of reamer handle snapped off leaving approx 1cm metal piece on the ground.Case continued with second reamer handle.30 second delay.Update: "no debris/components left inside of the patient and no components of the device missing or disassembled when the issue occurred." no.Surgical delay: 30 seconds.Case type: tha.
Additional Manufacturer Narrative
It was reported that surgeon just started reaming the acetabulum with straight reamer handle.Proximal end tip of reamer handle snapped off leaving approx 1cm metal piece on the ground.Case continued with second reamer handle.30 second delay update: "no debris/components left inside of the patient and no components of the device missing or disassembled when the issue occurred." no surgical delay: 30 seconds.Case type: tha.Product evaluation and results: not performed as no items were returned.Product history review: a review of the device history records could not be performed as lot number is unknown and the serial number provided is incorrect.Complaint history review: a review of the complaint history records could not be performed as lot number is unknown and the serial number provided is incorrect.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.
Event or Problem Description
Surgeon just started reaming the acetabulum with straight reamer handle.Proximal end tip of reamer handle snapped off leaving approx 1cm metal piece on the ground.Case continued with second reamer handle.30 second delay.Update: "no debris/components left inside of the patient and no components of the device missing or disassembled when the issue occurred." no.Surgical delay: 30 seconds.Case type: tha.

• Brand Name: STRAIGHT CUP REAMER HANDLE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8858297
• Report Number: 3005985723-2019-00550
• Device Sequence Number: 2717014
• Product Code: OLO
• UDI-Device Identifier: 00848486022204
• UDI-Public: 00848486022204
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121064
• 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): 12/20/2019

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: 207084
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 08/03/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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
• Patient Age: 83 YR