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

Model Number 112240

Device Problem Material Frayed (1262)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9837060
• MDR Text Key: 183653697
• Report Number: 3005985723-2020-00157
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486002930
• UDI-Public: 00848486002930
• Combination Product (y/n): N
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 112240
• Device Catalogue Number: 112240
• Device Lot Number: 19040715
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 75 YR