MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PRO-STIM 10CC INJECTABLE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	86SR0410
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bone graft hardened and was not able to be injected in the patient.Step by step directions were followed based on surgical technique but the tech was having a hard time doing everything in a timely manner.A second kit was opened to treat the patient.This was a delay in surgery of approximately 5 minutes.There were no adverse consequences to the patient or the surgery.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.
Additional Manufacturer Narrative
Correction d4 serial # should not be populated with the lot number.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a delay in the mixing process.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.
Event or Problem Description
It was reported that the bone graft hardened and was not able to be injected in the patient.Step by step directions were followed based on surgical technique but the tech was having a hard time doing everything in a timely manner.A second kit was opened to treat the patient.This was a delay in surgery of approximately 5 minutes.There were no adverse consequences to the patient or the surgery.

• Brand Name: PRO-STIM 10CC INJECTABLE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16530328
• Report Number: 3010667733-2023-00113
• Device Sequence Number: 2621610
• Product Code: MQV
• UDI-Device Identifier: 00840420143143
• UDI-Public: 00840420143143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083270
• 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): 05/02/2023

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: 06/29/2024
• Device Model Number: 86SR0410
• Device Catalogue Number: 86SR0410
• Device Lot Number: 1711226001
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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 Sex: Male