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

Catalog Number	213524
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
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
Dr.(b)(6) states that when drilling the 3.2 bone pin into the tibia there was an odd sound.Intra-incisional tibia pins were determined to be low enough to not interfere with press fit punch or implant.Upon removing the pin it was discovered that an about a cm of the threads had sheared off and was left in patient bone.A post op x-ray is scheduled to determine if pin caused a crack in bone.Case type: not reported.
Additional Manufacturer Narrative
Dr states that when drilling the 3.2 bone pin into the tibia there was an odd sound.Intra-incisional tibia pins were determined to be low enough to not interfere with press fit punch or implant.Upon removing the pin it was discovered that an about a cm of the threads had sheared off and was left in patient bone.A post op x-ray is scheduled to determine if pin caused a crack in bone.Update 18 nov 2019 information received from mps: post op x-ray showed that 1cm of the 3.2x110 was left in the patients bone.The keel punch was what caused the pin to break.No fracture was caused to bone.Dr.Is aware that intra-incisional tibia pin placement is off-label and now measures the keel before placing pins to prevent this from happening again.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the device history records indicate 513 devices were manufactured and accepted into final stock on 10/29/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 213524, l/n 48840618 shows 1 additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.
Event or Problem Description
Dr (b)(6) states that when drilling the 3.2 bone pin into the tibia there was an odd sound.Intra-incisional tibia pins were determined to be low enough to not interfere with press fit punch or implant.Upon removing the pin it was discovered that an about a cm of the threads had sheared off and was left in patient bone.A post op x-ray is scheduled to determine if pin caused a crack in bone.Case type: not reported.

• 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: 9077669
• Report Number: 3005985723-2019-00676
• Device Sequence Number: 2503060
• Product Code: OLO
• UDI-Device Identifier: 07613327412369
• UDI-Public: 07613327412369
• Combination Product (Y/N): N
• 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): 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: 213524
• Device Lot Number: 48840618
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2019
• 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