MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH #2 PS BOX CUTTING GUIDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	6541-5-712
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Additional information has been requested and if received will be provided in a supplemental report.Not returned.
Event or Problem Description
It was reported by the surgeon that a condylar fracture had occurred at some point during the total knee procedure.It was reported that the origin of the fracture is unclear.The fracture was reported to be fixed intra-operatively with 2 cancellous screws and a fiber-wire suture.It was reported that the additional time required for this complication was 20min.

• Brand Name: #2 PS BOX CUTTING GUIDE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7596625
• Report Number: 0002249697-2018-01795
• Device Sequence Number: 16187673
• Product Code: HRY
• UDI-Device Identifier: 07613327242812
• UDI-Public: 07613327242812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172326
• 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): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6541-5-712
• Device Lot Number: AL2E12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/13/2018
• 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; Required Intervention