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

Catalog Number 213524

Device Problems Break (1069); Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  malfunction  

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 Description

On (b)(6) 2019 during a mako tka procedure (b)(6) was trailing the newly designed 3.2x110 bone pins.(b)(6) put both the 3.2x110 bone pins into the tibia and placed the tibia array on.The tka procedure was completed successfully, when dr.(b)(6) went to take the tibia array off the tibia and remove the 3.2x110mm bone pins one the pins tip was broken off.Dr.(b)(6) showed me this and told me he never wanted to use these pins again.This is the same problem dr.(b)(6) had with the previous design on these bone pins.I looked at both pins and one defiantly was missing the tip.Both 3.2x110mm bone pins were cleaned and sterilized in order to send them back.Case type: tka.

Event Description

On (b)(6) 2019 during a mako tka procedure dr.(b)(6) was trialing the newly designed 3.2x110 bone pins.Dr.(b)(6) put both the 3.2x110 bone pins into the tibia and placed the tibia array on.The tka procedure was completed successfully, when dr.(b)(6) went to take the tibia array off the tibia and remove the 3.2x110mm bone pins one the pins tip was broken off.Dr.(b)(6) showed me this and told me he never wanted to use these pins again.This is the same problem dr.(b)(6) had with the previous design on these bone pins.I looked at both pins and one defiantly was missing the tip.Both 3.2x110mm bone pins were cleaned and sterilized in order to send them back.Case type: tka.Update: bone bin broke in the patient when the event occurred, debris/components left inside the patient.

Manufacturer Narrative

Reported event: on (b)(6) 2019 during a mako tka procedure dr.(b)(6) was trialing the newly designed 3.2x110 bone pins.Dr.(b)(6) put both the 3.2x110 bone pins into the tibia and placed the tibia array on.The tka procedure was completed successfully, when dr.(b)(6) went to take the tibia array off the tibia and remove the 3.2x110mm bone pins one the pins tip was broken off.Dr.(b)(6) showed me this and told me he never wanted to use these pins again.This is the same problem dr.(b)(6) had with the previous design on these bone pins.I looked at both pins and one defiantly was missing the tip.Both 3.2x110mm bone pins were cleaned and sterilized in order to send them back.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 11/06/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in trackwise related to p/n 213524, l/n 48280618 shows no additional complaints under investigation related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc capa associated with the product and failure mode reported in this event.

• Brand Name: BONE PIN, 3.2MM X 110MM, STERILE 2 PACK
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9141318
• MDR Text Key: 161392189
• Report Number: 3005985723-2019-00703
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327412369
• UDI-Public: 07613327412369
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213524
• Device Lot Number: 48280618
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR