MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TENDON SPACER SIZER 6MM; TEMPLATE

Catalog Number	24370006
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device not available.
Event or Problem Description
It was reported that the tendon spacer sizer was implanted in the patient.It was decided that a revision surgery would be performed to remove the sizer.
Additional Manufacturer Narrative
The reported event could be confirmed based on the information provided and the subsequent return of the complaint device.Examination of the returned device finds it is cut into 3 pieces.Suture threads are still present in the ends.The instrument is red as intended for the 6mm sizer.Sizers are intended to facilitate implant size determination and should not be implanted since they do not meet implant design specifications.Sizers are provided non-sterile and are color coded based on size.Implants are provided sterile and are clear / translucent.Label masters for the last two revisions were reviewed and confirmed the following statement, "caution: not for implantation" and non-sterile symbol was also found to be present.Based on investigation, the root cause was attributed to a user related issue.The event was caused by hcp and staff failing to identify the color coded sizer was not to be implanted.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the tendon spacer sizer was implanted in the patient.It was decided that a revision surgery would be performed to remove the sizer.

• Brand Name: TENDON SPACER SIZER 6MM
• Common Device Name: TEMPLATE
• 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: 18318730
• Report Number: 3010667733-2023-00763
• Device Sequence Number: 20697975
• Product Code: HWT
• UDI-Device Identifier: 00840420188410
• UDI-Public: 00840420188410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 24370006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown