MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC HUNTER TENDON ROD 3MM X 24.5CM; SPATULA, ORTHOPEDIC

Model Number	TR300000
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure that there was a discrepancy in the size of implant vs the size listed on the box.
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 during the procedure that there was a discrepancy in the size of implant vs the size listed on the box.
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the device was returned in the original carton.The carton confirmed the catalog to be tr300000 and lot to be 1709893.The carton was opened and inside the hunter tendon was in the inner tyvek pouch in an opened state.The label on the inner tyvek pouch also confirms the catalog and lot number.The hunter tendon was white and did not exhibit any abnormal damage or deformation.Dimensional measurments taken found the returned device to be within specifications.Based on investigation, the root cause was attributed to a user related issue.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.

• Brand Name: HUNTER TENDON ROD 3MM X 24.5CM
• Common Device Name: SPATULA, ORTHOPEDIC
• 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: 14749070
• Report Number: 3010667733-2022-00215
• Device Sequence Number: 2382589
• Product Code: HXR
• UDI-Device Identifier: 00840420128942
• UDI-Public: 00840420128942
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K853436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: TR300000
• Device Catalogue Number: TR300000
• Device Lot Number: 1709893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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