MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ADAPTOR ASSY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	112240
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
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
On (b)(6) 2020 at (b)(6), a surgical technician loosened the side piece of the array with her fingers to dissemble it during closing on the back table.During this, a small splinter of metal poked through her glove and pierced her finger.The metal splinter was taken out and she was sent for bloodwork.The defective piece was sterilized and will be sent back for a replacement.Case type: tka.
Additional Manufacturer Narrative
05/22/2020 update to b2 and d2.Reported event: on (b)(6) 2020 a surgical technician loosened the side piece of the array with her fingers to dissemble it during closing on the back table.During this, a small splinter of metal poked through her glove and pierced her finger.The metal splinter was taken out and she was sent for blood work.The defective piece was sterilized and will be sent back for a replacement.Case type: tka.Product evaluation and results: visual inspection confirms the pelvic array adapter metal shows signs of wear on the surface and splinters.See attached image for visual confirmation.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 01/11/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112240, l/n 19040715 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed as alleged via inspection.If device and/or additional information become available, this investigation will be reopened.
Event or Problem Description
On (b)(6) 2020 at (b)(6) health care, a surgical technician loosened the side piece of the array with her fingers to dissemble it during closing on the back table.During this, a small splinter of metal poked through her glove and pierced her finger.The metal splinter was taken out and she was sent for bloodwork.The defective piece was sterilized and will be sent back for a replacement.Case type: tka.

• Brand Name: PELVIC ARRAY ADAPTOR ASSY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9837060
• Report Number: 3005985723-2020-00157
• Device Sequence Number: 19220209
• Product Code: OLO
• UDI-Device Identifier: 00848486002930
• UDI-Public: 00848486002930
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 05/28/2020

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: 112240
• Device Catalogue Number: 112240
• Device Lot Number: 19040715
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/28/2020
• 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
• Patient Age: 75 YR