MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALORSUBTALAR OUTRIGGER GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	4150011002
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that a patient had an alignment issue regarding the outrigger-subtalar alignment.The patient suffered from charcot arthropathy and required an ankle fusion via a hindfoot nail for his procedure.No medical intervention reported during this event.Yes, a 10-minute delay occurred in attempting to re-align the screw trajectory to insert into the nail.Consequently, this attempt failed and the surgeon resorted to using cannulated screws.Additional consequences are to be determined.6 and 12-month post-operative follow-ups will indicate whether the ankle has successfully unsuccessfully fused and healed.Surgeon implanted cannulated screws outside and next to the intramedullary nail.No patient labels are available for review.No radiographic images from pre-op, peri-op and/or post-op available to provide any additional details related to this event.
Event or Problem Description
It was reported that a patient had an alignment issue regarding the outrigger-subtalar alignment.The patient suffered from charcot arthropathy and required an ankle fusion via a hindfoot nail for his procedure.No medical intervention reported during this event.Yes, a 10-minute delay occurred in attempting to re-align the screw trajectory to insert into the nail.Consequently, this attempt failed and the surgeon resorted to using cannulated screws.Additional consequences are to be determined.6 and 12-month post-operative follow-ups will indicate whether the ankle has successfully unsuccessfully fused and healed.Surgeon implanted cannulated screws outside and next to the intramedullary nail.No patient labels are available for review.No radiographic images from pre-op, peri-op and/or post-op available to provide any additional details related to this event.
Additional Manufacturer Narrative
Please see the corrections made to the d9/h3, h3: the reported event was confirmed since the device was not returned for evaluation and no other evidences were provided.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: VALORSUBTALAR OUTRIGGER GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 17241152
• Report Number: 3010667733-2023-00362
• Device Sequence Number: 6840836
• Product Code: FZX
• UDI-Device Identifier: 00889797035552
• UDI-Public: 00889797035552
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 08/02/2023

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 Model Number: 4150011002
• Device Catalogue Number: 4150011002
• Device Lot Number: 2436834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Unknown