MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	111653
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2020
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
When the checkpoint, 3.5 hex impaction was removed, the pin was broken.The broken part of the pin was removed safely.
Additional Manufacturer Narrative
Reported issue ¿ when the checkpoint, 3.5 hex impaction was removed, the pin was broken.The broken part of the pin was removed safely.Product identification ¿ the reported device was reported to be a mako checkpoint, 3.5 hex impaction sterile p/n 111653, lot number is not provided.Product inspection ¿ pr could not be confirmed as p/n 111653 mako checkpoint, 3.5 hex impaction sterile was not provided.Three communication attempts were made and appropriate information was not received.Product was not returned.Product history review ¿ product history review was not conducted as lot number was not provided.Complaint history review ¿ complaint history review was not conducted as lot number was not provided.Conclusion - pr could not be confirmed as p/n 111653 mako checkpoint, 3.5 hex impaction sterile was not provided.Three communication attempts were made and appropriate information was not received.Product was not returned.If additional information is received, then the complaint will be reopened.Device not returned.
Event or Problem Description
When the checkpoint, 3.5 hex impaction was removed, the pin was broken.The broken part of the pin was removed safely.

• Brand Name: CHECKPOINT, 3.5 HEX IMPACTION STERILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10038184
• Report Number: 3005985723-2020-00199
• Device Sequence Number: 2812690
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• 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): 07/02/2020

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: 111653
• Device Catalogue Number: 111653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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: Other