MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC CHARLOTTE®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	44180025
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the surgeon was putting in the nail screws with the ratcheting handle and said the handle was broken.This was after putting in several screws.Used a synthes t- handle and had about a 10 min delay.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device does function as intended.The device inspection revealed the following: visual inspection: examination of the returned device finds no damage/deformation to the handle, locking mechanism, or cannulation.The ball bearings that facilitate locking onto the drivers are in place as designed.There are slight scratches and blemishes consistent with a reusable device.Functional inspection: a test driver was used to functionally test the ratcheting and locking function of the handle.The test driver was able to insert into the driver as intended and remained in place once the locking slide was returned to the distal position even when force was applied.Once locked in position, the handle was able to ratchet as intended in both directions.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the surgeon was putting in the nail screws with the ratcheting handle and said the handle was broken.This was after putting in several screws.Used a synthes t- handle and had about a 10 min delay.

• Brand Name: CHARLOTTE®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13424217
• Report Number: 3010667733-2022-00035
• Device Sequence Number: 3915114
• Product Code: LXH
• UDI-Device Identifier: 00840420191779
• UDI-Public: 00840420191779
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 44180025
• Device Catalogue Number: 44180025
• Device Lot Number: 2229636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown