MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Model Number	143140
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
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
Tka was performed with mako system.To locate femoral array, bone pin was drilled into femoral shaft.Tried to fix bicortically, but couldn't drill inner cortex.Removed bone pin and found tip of the pin broken.Used another bone pin.The tip of the pin was remained in femoral intraspinal.Impossible to remove broken piece, so finished surgery without removing it.Update: "please estimate any surgical delay, even if under a minute (or indicate ¿none¿ to confirm there was absolutely no delay): approximately 10 minutes.".
Additional Manufacturer Narrative
Reported event: tka was performed with mako system.To locate femoral array, bone pin was drilled into femoral shaft.Tried to fix bicortically, but couldn't drill inner cortex.Removed bone pin and found tip of the pin broken.Used another bone pin.The tip of the in was remained in femoral intraspinal.Impossible to remove broken piece, so finished surgery without removing it.Update: "please estimate any surgical delay, even if under a minute (or indicate ¿none¿ to confirm there was absolutely no delay): approximately 10 minutes".Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the product history records cannot be conducted as the lot number provided is incorrect.Complaint history review: review of the complaint history records cannot be conducted as the lot 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.
Event or Problem Description
Tka was performed with mako system.To locate femoral array, bone pin was drilled into femoral shaft.Tried to fix bicortically, but couldn't drill inner cortex.Removed bone pin and found tip of the pin broken.Used another bone pin.The tip of the in was remained in femoral intraspinal.Impossible to remove broken piece, so finished surgery without removing it.Update: " please estimate any surgical delay, even if under a minute (or indicate ¿none¿ to confirm there was absolutely no delay): approximately 10 minutes".

• Brand Name: BONE PIN, 3.2MM X 140MM, 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: 9664952
• Report Number: 3005985723-2020-00069
• Device Sequence Number: 14087098
• Product Code: OLO
• UDI-Device Identifier: 00848486018146
• UDI-Public: 00848486018146
• Combination Product (Y/N): N
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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 Model Number: 143140
• Device Catalogue Number: 143140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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