MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 110MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	143110
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
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
Mako tibial 3.2 x110mm pins bent and broke off inside patient upon removal at end of case.See attached images.Mako 3.2x110mm pins, one item affected out of pack of 2 procedure: mako left total knee.
Event or Problem Description
Mako tibial 3.2 x110mm pins bent and broke off inside patient upon removal at end of case.See attached images.Mako 3.2x110mm pins, one item affected out of pack of 2.Procedure: mako left total knee.
Additional Manufacturer Narrative
Mako tibial 3.2 x110mm pins bent and broke off inside patient upon removal at end of case.See attached images.Mako 3.2x110mm pins, one item affected out of pack of 2 procedure: mako left total knee.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 05/03/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 143110, l/n w64079-2 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed as alleged as per the image provided.If device and/or additional information become available, this investigation will be reopened.

• Brand Name: BONE PIN, 3.2MM X 110MM, STERILE 2 PACK
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9076685
• Report Number: 3005985723-2019-00677
• Device Sequence Number: 16763488
• Product Code: OLO
• UDI-Device Identifier: 00848486018139
• UDI-Public: 00848486018139
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112507
• 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): 12/19/2019

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: 143110
• Device Lot Number: W640792
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/23/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 72 YR