PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
Report
- Report Number
- 3010667733-2022-00425
- Event Type
- Malfunction
- Date Received
- December 2, 2022
- Date of Event
- November 2, 2022
- Report Date
- June 28, 2023
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY INC
- Product Code
- HSN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE CLEARED 510K # K131283. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. AN INDEPENDENT INVESTIGATION WAS CONDUCTED BY THE PROPHECY TEAM AND THE FOLLOWING WERE NOTED: THE CT SCAN WAS PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ERRORS WERE IDENTIFIED DURING THE SEGMENTATION PROCEDURE. 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. NO ROOT CAUSE IDENTIFIED: IT WAS NOT POSSIBLE TO IDENTIFY WHAT CAUSED THE PROPHECY GUIDE INACCURACY MENTIONED IN THE COMPLAINT¿S EMAIL. A POTENTIAL ROOT CAUSE MAY BE A DISCREPANCY IN USER EXPECTATIONS VS GUIDE FIT AND FEEL DURING SURGERY OR USER ERROR DURING SURGERY. 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. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN.
CORRECTION - D9 / H3 (PRODUCT AVAILABLE TO STRYKER), H3 (DEVICE EVALUATED BY MFG), H6 (METHOD CODE 2 AND 3, RESULTS CODE, CONCLUSION CODE) THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE RETURNED PROPHECY GUIDES ARE CONFORMING TO SPECIFICATIONS AND FULLY FUNCTIONAL. THE DEVICE INSPECTION REVEALED THE FOLLOWING: NO VISIBLE DAMAGES COULD BE FOUND AROUND THE TALUS AND TIBIAL GUIDE AND BONE MODEL. KEY DIMENSIONAL MEASUREMENTS FOR THE LENGTH, WIDTH AND HEIGHT OF THE TALUS AND TIBIAL GUIDE WERE TAKEN WITH A DIGITAL CALIPER AND FOUND TO BE WITHIN DIMENSIONAL SPECIFICATIONS. THE HOLES OF THE TALUS AND TIBIAL GUIDE WERE MEASURED TO BE 0.0975 IN. A GAGE PIN WAS USED TO VERIFY THE DIMENSIONS OF THE HOLES FOR THE TALUS AND TIBIAL GUIDE. THE GAGE PIN WAS ABLE TO PASS THROUGH THE HOLES CONFIRMING THE GUIDES WERE MANUFACTURED TO SPECIFICATION. BOTH THE TALUS AND TIBIAL GUIDE WERE ABLE TO BE POSITIONED CORRECTLY ON THEIR RESPECTIVE BONE MODELS. AN INVESTIGATION WAS CONDUCTED BY THE PROPHECY TEAM AND THE FOLLOWING WERE NOTED: ¿ THE CT SCAN WAS PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ERRORS WERE IDENTIFIED DURING THE SEGMENTATION PROCEDURE. 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. NO ROOT CAUSE IDENTIFIED: IT WAS NOT POSSIBLE TO IDENTIFY WHAT CAUSED THE PROPHECY GUIDE INACCURACY MENTIONED IN THE COMPLAINT¿S EMAIL. A POTENTIAL ROOT CAUSE MAY BE A DISCREPANCY IN USER EXPECTATIONS VS GUIDE FIT AND FEEL DURING SURGERY OR USER ERROR DURING SURGERY. 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 MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.
IT WAS REPORTED THAT THE PROPHECY GUIDE WAS NOT ACCURATE AND COULD NOT BE USED. THE OPERATION COULD BE PERFORMED CONVENTIONALLY. ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN.
IT WAS REPORTED THAT THE PROPHECY GUIDE WAS NOT ACCURATE AND COULD NOT BE USED. THE OPERATION COULD BE PERFORMED CONVENTIONALLY. ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN.
IT WAS REPORTED THAT THE PROPHECY GUIDE WAS NOT ACCURATE AND COULD NOT BE USED. THE OPERATION COULD BE PERFORMED CONVENTIONALLY. ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2536332 | PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | HSN | WRIGHT MEDICAL TECHNOLOGY INC | 1743098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |