MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number PROPINFE

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported that the patient id on the prophecy guide could not be identified.No patient impact.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The event involves a device that is not cleared for sale in the u.S., but a similar device, part #propinf, is commercially available cleared 510k k131283.H3 other text : device not available.

Event Description

It was reported that the patient id on the prophecy guide could not be identified.No patient impact.

Manufacturer Narrative

The complaint could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Prophecy team reviewed the received information and noted: conclusions: ¿ the alignment guides were designed within normal, acceptable ranges no abnormalities in the internal process were found.¿ the engineering drawings and quality documents were processed within normal, acceptable ranges no abnormalities in the internal process were found.¿ the standard identifier for the packaging and the guides are the case number and surgeon¿s last name patient initials or another patient identifier is not included.No root cause identified: ¿ no error in the internal process was found regarding the guide labeling and other case identifiers in the packaging.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 17969994
• MDR Text Key: 326118505
• Report Number: 3010667733-2023-00615
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Catalogue Number: PROPINFE
• Device Lot Number: 1766997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1