MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH MOD FEM TRIAL IMPACTOR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	71442161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that trial impactor broke while being used during surgery.No delay or injury reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the provided pictures confirmed the stated failure mode.The plastic bumper on the device fractured and had numerous nicks and gouges in surface.A review of complaint history did not reveal additional complaints for the listed batch.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 MOD FEM TRIAL IMPACTOR
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8722174
• Report Number: 1020279-2019-02382
• Device Sequence Number: 19349195
• Product Code: JWH
• UDI-Device Identifier: 00885556583791
• UDI-Public: 00885556583791
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 71442161
• Device Lot Number: 18CBG0003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1