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

Model Number	213527
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/27/2020
Type of Reportable Event	Serious Injury
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
On (b)(6) 2020, the patient underwent tka (left) for knee joint.Postoperative fracture occurred from the position of the pin insertion for femoral array installation.So, the patient under went revision on (b)(6) 2020.
Additional Manufacturer Narrative
Reported event: on (b)(6) 2020, the patient underwent tka (left) for knee joint.Postoperative fracture occurred from the position of the pin insertion for femoral array installation.So, the patient under went revision on (b)(6) 2020.If you have similar reports in japan or overseas, please let us know as soon as possible.Please report any fractures not only with mako but also with navi pins.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: a review of the device history records could not be performed as lot number was not provided.Complaint history review: a complaint history review could not be performed as lot number was not provided.Conclusions: the alleged failure mode could not be confirmed 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
On (b)(6) 2020, the patient underwent tka (left) for knee joint.Postoperative fracture occurred from the position of the pin insertion for femoral array installation.So, the patient under went revision on (b)(6) 2020.

• Brand Name: BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10740218
• Report Number: 3005985723-2020-00321
• Device Sequence Number: 3195629
• Product Code: OLO
• UDI-Device Identifier: 07613327412376
• UDI-Public: 07613327412376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191998
• 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): 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 213527
• Device Catalogue Number: 213527
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/15/2021
• 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; Required Intervention
• Patient Age: 67 YR