MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON SIZER-BALANCER HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	I-K2291KB00
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr.Was doing a mako knee and we noticed before the case the tensor was damaged.

• Brand Name: SPECIALTY TRIATHLON SIZER-BALANCER HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9197473
• Report Number: 0002249697-2019-03522
• Device Sequence Number: 10865027
• Product Code: LXH
• UDI-Device Identifier: 07613327334371
• UDI-Public: 07613327334371
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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 Expiration Date: 10/31/2022
• Device Catalogue Number: I-K2291KB00
• Device Lot Number: AP12S28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/16/2019
• 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