MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH MOD FEM TRIAL IMPACTOR; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71442161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the impactor broke while impacting the femoral component trial.A backup device was available and more than 30 minutes of delay was reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical analysis indicated that reportedly during a primary right tkr the implant impactor broke during use.A back up device was available and no patient injury is being reported.Since no harm to the patient is being reported, no further medical assessment is warranted.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: ORTHOMATCH MOD FEM TRIAL IMPACTOR
• 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: 8370472
• Report Number: 1020279-2019-00808
• Device Sequence Number: 11186401
• Product Code: JWH
• UDI-Device Identifier: 00885556583791
• UDI-Public: 00885556583791
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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): 06/18/2019

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
• Initial Date Received by Manufacturer: 02/02/2019
• Supplement Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 90