MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 4MM X 110MM, STERILE 2 PACK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	144110
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2020
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
The surgeon started removing the 4 x 110 tibial pin and it broke off in the patient's tibia.He decided to leave it in place, commenting that it should be an issue since it was buried.Case type: tka.
Additional Manufacturer Narrative
Reported event: the surgeon started removing the 4 x 110 tibial pin and it broke off in the patient's tibia.He decided to leave it in place, commenting that it should be an issue since it was buried.Case type: tka.Updated 4/27/20 - based on information provided during intake and additional information from customer contact the statement should've been the following: "he decided to leave it in place, commenting that it shouldn't be an issue since it was buried." product evaluation and results: product inspection could not be performed as the product was not returned for evaluation.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 01/31/2020.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 144110, l/n w68178-2 shows no additional complaints related to the failure in this investigation.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.H3 other text : device not returned.
Event or Problem Description
The surgeon started removing the 4 x 110 tibial pin and it broke off in the patient's tibia.He decided to leave it in place, commenting that it should be an issue since it was buried.Case type: tka.

• Brand Name: BONE PIN, 4MM X 110MM, 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: 9911496
• Report Number: 3005985723-2020-00186
• Device Sequence Number: 3131004
• Product Code: OLO
• UDI-Device Identifier: 00848486018160
• UDI-Public: 00848486018160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/01/2020

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: 144110
• Device Catalogue Number: 144110
• Device Lot Number: W68178-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 06/01/2020
• 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; Other