MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH FEMORAL SIZER; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71442194
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the instrument was broken.No delay was reported and no backup device was available.Procedure finished free hands.
Additional Manufacturer Narrative
The associated complaint device was not returned.A visual evaluation of the provided pictures confirmed the stated failure mode.The device was disassembled.The device was not returned for evaluation so a probable cause for the disassembly could not be determined.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.A review of the manufacturing records for the listed batch did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: ORTHOMATCH FEMORAL SIZER
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8719985
• Report Number: 1020279-2019-02358
• Device Sequence Number: 16740800
• Product Code: JWH
• UDI-Device Identifier: 00885556583746
• UDI-Public: 00885556583746
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71442194
• Device Catalogue Number: 71442194
• Device Lot Number: 16HBG002B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2020
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019; 12/15/2020
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 10/20/2019; 12/17/2020
• 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; Required Intervention