MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PIN SLEEVE INFINITY TOTAL ANKLE SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	33600025
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " the procedure for the placement of the ankle prosthesis was standard until we wanted to put the pin sleeves in the holes of the distal part of the alignment jig.Impossible to put the 2 sleeves in 2 holes of the guide.Even less possible to put 2 sockets in the axis as required by the operating technique.We have tried everything to avoid the handling error, without success.We tried to find a solution to adapt, but found no alternative to continue the procedure.The event was discovered during the placement of the sleeves in the alignment jig holes as mentioned above.Steps/actions taken to complete the procedure: the surgeon made the decision to perform an ankle plate arthrodesis.The duration of the procedure was therefore longer than a conventional plate arthrodesis.".
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
Correction: h3, h6 method code this device is concomitant and did not contribute to the reported failure.¿ therefore, this complaint is closed without further investigation.¿ if any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.Device not returned.
Event or Problem Description
It was reported that " the procedure for the placement of the ankle prosthesis was standard until we wanted to put the pin sleeves in the holes of the distal part of the alignment jig.Impossible to put the 2 sleeves in 2 holes of the guide.Even less possible to put 2 sockets in the axis as required by the operating technique.We have tried everything to avoid the handling error, without success.We tried to find a solution to adapt, but found no alternative to continue the procedure.The event was discovered during the placement of the sleeves in the alignment jig holes as mentioned above.Steps/actions taken to complete the procedure: the surgeon made the decision to perform an ankle plate arthrodesis.The duration of the procedure was therefore longer than a conventional plate arthrodesis.".

• Brand Name: PIN SLEEVE INFINITY TOTAL ANKLE SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL 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: 16247663
• Report Number: 3010667733-2023-00041
• Device Sequence Number: 6313356
• Product Code: LXH
• UDI-Device Identifier: 00889797003971
• UDI-Public: 00889797003971
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/03/2023

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: 33600025
• Device Catalogue Number: 33600025
• Device Lot Number: 2694029
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown