MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY MONOGRAM PATELLA OUTRIGGER FOR XCELERATE CUTTERS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	I-K4112OT00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Custom patella reamer was presented to surgeon for sawbone demo and the shaft gets stuck when fully engaged.
Event or Problem Description
Custom patella reamer was presented to surgeon for sawbone demo and the shaft gets stuck when fully engaged.
Additional Manufacturer Narrative
An event regarding annoyance involving a specialty monogram patella outrigger was reported.Review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.There have been no other events for the lot referenced.Conclusion: the device was discovered during a demonstration.The device was returned in new condition and found to be functionally within specification however, the outrigger locks on the shoulder of the mill which is not it¿s intended use.The instrument was submitted for a dimensional inspection and found that this failure would always occur.An nc was opened on 8-apr-2019 to prevent this failure from reoccurring by revising the design of the instrument and associated documents.Further, the nc designated the device as "use-as-is." there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SPECIALTY MONOGRAM PATELLA OUTRIGGER FOR XCELERATE CUTTERS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8433737
• Report Number: 0002249697-2019-01367
• Device Sequence Number: 11266474
• Product Code: LXH
• UDI-Device Identifier: 07613327418965
• UDI-Public: 07613327418965
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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 Catalogue Number: I-K4112OT00
• Device Lot Number: AP13T51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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: Other