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	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
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
Surgeon began placing pin in hip for array placement (non operative hip for da approach).Surgeons stated he barely broke bin when the tip broke off.Patient was x-rayed and tip of pin was removed from the bone.Case type: tha.
Additional Manufacturer Narrative
Reported issue- surgeon began placing pin in hip for array placement (non operative hip for da approach).Surgeons stated he barely broke bin when the tip broke off.Patient was x-rayed and tip of pin was removed from the bone.Product inspection - as per the image provided in the communication log , the broken pin can be seen and confirmed.Also the device has been discarded by the hospital.Product history review ¿ review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 03/05/2019.No non-conformances were identified during inspection.Complaint history review - a review of complaints in catsweb and trackwise related to p/n 213527, lot 48100219 shows no additional complaint related to the failure in this investigation.Conclusion ¿ the failure is confirmed via visual inspection of the image provided in the communication log.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
Surgeon began placing pin in hip for array placement (non operative hip for da approach).Surgeons stated he barely broke bin when the tip broke off.Patient was x-rayed and tip of pin was removed from the bone.Case type: tha.

• 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: 9757994
• Report Number: 3005985723-2020-00106
• Device Sequence Number: 14154847
• Product Code: OLO
• UDI-Device Identifier: 07613327412376
• UDI-Public: 07613327412376
• 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): 05/14/2020

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: 213527
• Device Catalogue Number: 213527
• Device Lot Number: 48100219
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/14/2020
• 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
• Patient Age: 31 YR