MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 110MM, STERILE 2 PACK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	143110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
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
During the first case of the day (pka) in (b)(6), the doctor noticed that the 3.2mm pins broke while he was screwing.(b)(4) lot w50726-2.Update: was the patient in the operating room at the time of event? yes.Was the patient under anesthesia? yes.Did the device break in the patient? yes.Were all pieces removed? no.If not, why not? broken part too deep in bone.Left or right side: right.Was surgical procedure completed manually (yes/ no/ no associated procedure)? no, with mako till the end.Rio system details: (b)(4).
Additional Manufacturer Narrative
Update to b2 and d2.Reported event: during the first case of the day (pka) in (b)(6), dr.(b)(6) noticed that the 3.2mm pins broke while he was screwing.Lot w50726-2.Update: "1.Was the patient in the operating room at the time of event?yes 1.Was the patient under anesthesia?yes 2.Did the device break in the patient?yes 1.Were all pieces removed?no 2.If not, why not? broken part too deep in bone left or right side:right was surgical procedure completed manually (yes/ no/ no associated procedure)? no, with mako till the end.Rio system details: o rob#: (b)(4)" product evaluation and results: visual inspection confirm the bone pin has fragmented and can be seen in attached image.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 05/18/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 143110, l/n w50726-2 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed via inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
During the first case of the day (pka) in (b)(6), the doctor noticed that the 3.2mm pins broke while he was screwing.Ref143110 lot w50726-2.Update: 1.Was the patient in the operating room at the time of event? yes.1.Was the patient under anesthesia? yes.2.Did the device break in the patient? yes.1.Were all pieces removed? no.2.If not, why not? broken part too deep in bone left or right side :right was surgical procedure completed manually (yes/ no/ no associated procedure)? no, with mako till the end.Rio system details: o rob#: (b)(4)".

• Brand Name: BONE PIN, 3.2MM 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: 9850127
• Report Number: 3005985723-2020-00165
• Device Sequence Number: 19023910
• Product Code: OLO
• UDI-Device Identifier: 00848486018139
• UDI-Public: 00848486018139
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/12/2020

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: 143110
• Device Catalogue Number: 143110
• Device Lot Number: W50726-2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 06/12/2020
• 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