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

Model Number	PROPINB
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a total ankle replacement procedure.During the surgery, the physician had an issue with the prophecy blocks.The block pin holes did not line up with the size 4 corresponding resection guide (or size 3 which was tested as well).After pinning the prophecy block, the surgical team attempted to place the resection block over the wires in the tibial cut prox corners per the usual technique and the pins were off by 3-4 mm.The physician had to line up the size 4 resection guide to the prophecy block to create a new hole that matched the resection block.There was a surgical delay because the surgeon had to create new holes in the prophecy block essentially rendering them useless.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Hospital retained the device.
Event or Problem Description
It was reported that the patient presented for a total ankle replacement procedure.During the surgery, the physician had an issue with the prophecy blocks.The block pin holes did not line up with the size 4 corresponding resection guide (or size 3 which was tested as well).After pinning the prophecy block, the surgical team attempted to place the resection block over the wires in the tibial cut prox corners per the usual technique and the pins were off by 3-4 mm.The physician had to line up the size 4 resection guide to the prophecy block to create a new hole that matched the resection block.There was a surgical delay because the surgeon had to create new holes in the prophecy block essentially rendering them useless.
Additional Manufacturer Narrative
Based on further investigation and review of the new information received the reportability decision was revised to non-reportable, as the reported malfunction have not caused or contributed to death or serious injury.The review of the risk documentation and the reported information regarding this event do not suggest a recurrence of this event would result in a death or serious injury.The surgery was completed successfully without any patient or end user impact.Investigation results have revealed that the root cause was attributed to an isolated manufacturing error.A nonconformance was initiated to further address the issue.The current operative technique was reviewed and states: "the surgeon can choose to revert back to the traditional inbone® foot holder surgical technique if there are any concerns with the planned resection, therefore such procedure can still be completed without the use of the patient specific guides.Product surveillance will continue to monitor complaints of this type for adverse trends.

• Brand Name: PROPHECY INBONE PATIENT SPECIFIC GUIDES
• Common Device Name: 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: 15696374
• Report Number: 3010667733-2022-00368
• Device Sequence Number: 6763573
• Product Code: HSN
• UDI-Device Identifier: 00889797057110
• UDI-Public: 00889797057110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 03/26/2023
• Device Model Number: PROPINB
• Device Catalogue Number: PROPINB
• Device Lot Number: 1743357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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