MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STRAIGHT CUP REAMER HANDLE; STEREOTAXIC DEVICE, ROBOTICS

Model Number 207084

Device Problems Degraded (1153); Material Fragmentation (1261)

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

Event Date 10/01/2019

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

Event description :the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer.Case type: tha.Surgical delay: =15 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.It was reported that the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer.Case type: tha surgical delay: =15 minutes product evaluation and results: as per the image provided in the communication, it shows that the metal on the back of the straight reamer is stripped.Further inspection not performed as no items were returned.Product history review: review of the device history records indicate 98 devices were manufactured and accepted into final stock on 02-16-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 207084, lot 06021216 shows 1 additional complaint related to the failure in this investigation.The complaint is pr: (b)(4).Conclusions: the failure is confirmed from 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.

Event Description

Event description :the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer.Case type: tha surgical delay: =15 minutes.

• Brand Name: STRAIGHT CUP REAMER HANDLE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9237971
• MDR Text Key: 175243061
• Report Number: 3005985723-2019-00761
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486022204
• UDI-Public: 00848486022204
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 207084
• Device Catalogue Number: 207084
• Device Lot Number: 06021216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization