MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ALIGNMENT FRAME DIST SUB ASSEM INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33600020
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	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event, alleged of issue, "instrument ¿ assembling impaired outside of surgery" could be confirmed since the returned devices match the alleged failure mode.The device inspection revealed the following: two alignment frame devices were received under the same lot number.Slight blemishes and scratches could be seen around both devices.However, no significant deformations were visible within the inner holes of the instruments.The middle proximal hole for one of the returned devices was found to be jammed with a pin sleeve.The pin sleeve for the jammed alignment frame device could not be removed.A pin sleeve with the same catalog number as the jammed pin sleeve was used to test the holes of both alignment frame devices.The pin sleeve was unable to pass through all three distal holes and the other two unblocked proximal holes for the jammed alignment frame device.The same pin sleeve was used to test the holes of the unjammed alignment frame device.The pin sleeve was unable to pass through all three distal holes and two of the proximal holes.A 0.233 minus gage pin was used to verify the dimensions of the holes for both returned devices.The gage pin could not pass through all the unblocked holes of the jammed alignment frame device.The gage pin could not pass through all six holes of the unjammed alignment frame device.Therefore, it can be confirmed that both returned devices were not manufactured to specification.Based on investigation, the root cause was attributed to a manufacturing related issue.A nonconformance was opened to further address the issue.
Event or Problem Description
It was reported that the pins do not fit into the mating parts of a distal alignment frame.The pin is to spec but the frame has inconsistent sizes of holes.

• Brand Name: ALIGNMENT FRAME DIST SUB ASSEM INFINITY TOTAL ANKLE SYSTEM
• 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: 16979896
• Report Number: 3010667733-2023-00271
• Device Sequence Number: 17776396
• Product Code: HSN
• UDI-Device Identifier: 00889797003926
• UDI-Public: 00889797003926
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: 33600020
• Device Catalogue Number: 33600020
• Device Lot Number: 2656815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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