MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TENDON SPACER SWANSON/HUNTER 24CM X 3MM FLEXSPAN; PROSTHESIS, TENDON, PASSIVE

Catalog Number	24270003
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that an expired implant was implanted into a patient on (b)(6) 2025 as per the following: the expired tendon spacer was inserted into the patient with the surgeons knowledge and consent.
Additional Manufacturer Narrative
The reported event could be confirmed since the date the device was implanted was confirmed to be after the expiration.The product was not returned, however evaluation of the dhr and labeling does confirm the expiration date was correctly printed on all labels.Furthermore, it was noted the device was not a loan or a consignment.The hospital team knowingly implanted an expired item since they had no others available.Based on the investigation, the root cause can be attributed a user related issue.The surgeon knowingly decided to use the product off-label.In general it can be stated that in case of the expiration of shelf life stryker cannot guarantee the performance and safety for use.The risk of infection will increase with the time passed after the expiry date which is printed on the packaging.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.
Event or Problem Description
It was reported that an expired implant was implanted into a patient on (b)(6)2025 as per the following - the expired tendon spacer was inserted into the patient with the surgeons knowledge and consent.

• Brand Name: TENDON SPACER SWANSON/HUNTER 24CM X 3MM FLEXSPAN
• Common Device Name: PROSTHESIS, TENDON, PASSIVE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22018275
• Report Number: 3010667733-2025-00561
• Device Sequence Number: 12945017
• Product Code: HXA
• UDI-Device Identifier: 00840420121851
• UDI-Public: (01)00840420121851(11)170307(17)250305(10)1595956
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 24270003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 03/05/2025
• Device Catalogue Number: 24270003
• Device Lot Number: 1595956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2017
• 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: Unknown