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

Model Number	87SRCDK0
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Product was opened for case.Pro dense 15cc was mixed properly following directions.When surgeon began to implant prodense mixture would not come out of syringe.All material in syringe had hardened before coming out of syringe to implant in patient.Took apart on back table.All prodense was hardened and unable to implant.Was within working time for mixing parameters, with plenty of time left over to implant.The surgeon used pro-stim 15cc to inject in patient.No complications.No delay that required additional anesthesia, medication, surgical procedure, or the use of unintended equipment.
Event or Problem Description
Product was opened for case.Pro dense 15cc was mixed properly following directions.When surgeon began to implant prodense mixture would not come out of syringe.All material in syringe had hardened before coming out of syringe to implant in patient.Took apart on back table.All prodense was hardened and unable to implant.Was within working time for mixing parameters, with plenty of time left over to implant.The surgeon used pro-stim 15cc to inject in patient.No complications.No delay that required additional anesthesia, medication, surgical procedure, or the use of unintended equipment.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Successful use of the product requires the surgical team to accurately control mixing time, mixing speed, complete mixing, use of all components supplied, using only those components supplied in the kit (no substitution).Any variable outside the parameters supplied in the mixing instructions may affect the chemical and physical properties of the product.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.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 more information is provided, the case 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: 13476795
• Report Number: 3010667733-2022-00040
• Device Sequence Number: 5462110
• Product Code: MQV
• UDI-Device Identifier: 00889797072724
• UDI-Public: 00889797072724
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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 Expiration Date: 05/19/2026
• Device Model Number: 87SRCDK0
• Device Catalogue Number: 87SRCDK0
• Device Lot Number: 1708294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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: 50 YR
• Patient Sex: Male