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

Model Number	87SR0100
Medical Device Problem Codes	Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
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.
Event or Problem Description
It was reported that the 10cc prodense unit was mixed and upon delivery would not exit the delivery needle after 4 minutes when filling screw tracks in the hip after hardware was removed.2 of the three screw holes were filled before the prodense would not exit the delivery needle.One screw hole was not filled with prodense.This resulted in a 3-4 minute delay in surgery.
Event or Problem Description
It was reported that the 10cc prodense unit was mixed and upon delivery would not exit the delivery needle after 4 minutes when filling screw tracks in the hip after hardware was removed.2 of the three screw holes were filled before the prodense would not exit the delivery needle.One screw hole was not filled with prodense.This resulted in a 3-4 minute delay in surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 as well as the affected device must be available in order to determine the root cause of the complaint event.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.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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15606339
• Report Number: 3010667733-2022-00352
• Device Sequence Number: 14006988
• Product Code: MQV
• UDI-Device Identifier: 00889797072762
• UDI-Public: 00889797072762
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 11/03/2025
• Device Model Number: 87SR0100
• Device Catalogue Number: 87SR0100
• Device Lot Number: 1696596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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: 15 YR
• Patient Sex: Male
• Patient Weight: 68 KG