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

Model Number	71442161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the impactor broke down during surgery.The device broke outside the patient and no pieces fell inside the surgical incision.No delay reported.No patient injuries reported.An s and n backup was available.
Additional Manufacturer Narrative
The device, used treatment was not returned for evaluation, reporting event could not be confirmed.A visual inspection of the attached photo confirms that the impactor body has fractured.This failure mode has been previously identified.A design change has been implemented to reduce/eliminate this failure mode from recurrence.This device was manufactured prior to these corrective actions.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, corrective and preventive action is indicated to mitigate future recurrence of similar events.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• 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: 9935271
• Report Number: 1020279-2020-01212
• Device Sequence Number: 755233
• Product Code: JWH
• UDI-Device Identifier: 00885556583791
• UDI-Public: 00885556583791
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71442161
• Device Catalogue Number: 71442161
• Device Lot Number: 16FBG0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 12/15/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/26/2020; 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1