MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH DCF AP CUTTING BLOCK SZ 3; PROSTHESIS, KNEE, , SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number 71442103

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the middle grooves protrude and cannot be combined to operate correctly the surgeon control it with general strength by free hand.No patient injury or other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: ORTHOMATCH DCF AP CUTTING BLOCK SZ 3
• Type of Device: PROSTHESIS, KNEE, , SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9581036
• MDR Text Key: 174711516
• Report Number: 1020279-2020-00237
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K142807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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
• Device Operator: No Information
• Device Catalogue Number: 71442103
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1