MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DIRECT MEASURE 4.0MM; PLATE, FIXATION, BONE

Model Number	71117083
Medical Device Problem Codes	Corroded (1131); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that it was noticed by the healthcare facility that there is rust on the equipment and numbers are wearing off.No case or patient was involved.Device was thrown out.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.Per photo attached to the complaint, confirms the product marking is fading.The photo can not confirm the rust issue.We are unable confirm what the rust issue until the item is returned for evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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, the need for corrective action is not indicated.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.Case-2020-00028109-1.

• Brand Name: DIRECT MEASURE 4.0MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10956136
• Report Number: 1020279-2020-07037
• Device Sequence Number: 3188908
• Product Code: HRS
• UDI-Device Identifier: 03596010173898
• UDI-Public: 03596010173898
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 71117083
• Device Catalogue Number: 71117083
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 12/06/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1