MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PRO-DENSE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	87SR0420
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.
Event or Problem Description
The hospital staff did not mix the product successfully and the doctor requested we do not charge the patient for this item as it was not used.No patient complications were reported.
Event or Problem Description
The hospital staff did not mix the product successfully and the doctor requested we do not charge the patient for this item as it was not used.No patient complications were reported.
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 any additional information is provided, the investigation will be reassessed.

• Brand Name: PRO-DENSE
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• 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: 13122191
• Report Number: 3010667733-2021-00031
• Device Sequence Number: 11902666
• Product Code: MQV
• UDI-Device Identifier: 00840420137296
• UDI-Public: 00840420137296
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060011
• 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): 02/09/2022

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 Expiration Date: 10/26/2023
• Device Model Number: 87SR0420
• Device Catalogue Number: 87SR0420
• Device Lot Number: 1695531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female