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

Model Number	207084
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9237971
• Report Number: 3005985723-2019-00761
• Device Sequence Number: 145889
• Product Code: OLO
• UDI-Device Identifier: 00848486022204
• UDI-Public: 00848486022204
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/28/2020

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: 207084
• Device Catalogue Number: 207084
• Device Lot Number: 06021216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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