MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC MTP FUSION SMALL 10DG RT ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Catalog Number	587111RT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by sales agent: "surgeon put plate on and fixed with one screw distally.Went to put second locking screw in and said screw wouldn¿t lock in.Tried several methods to lock in but surgeon believes threads on plates faulty.Removed plate and swapped to standard ortholoc mtp fusion plate.No further issues.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported by sales agent: "surgeon put plate on and fixed with one screw distally.Went to put second locking screw in and said screw wouldn¿t lock in.Tried several methods to lock in but surgeon believes threads on plates faulty.Removed plate and swapped to standard ortholoc mtp fusion plate.No further issues.".
Additional Manufacturer Narrative
Correction - please refer to d9 - the product was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 re-assessed.

• Brand Name: MTP FUSION SMALL 10DG RT ORTHOLOC 3DI PLATING SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 20153766
• Report Number: 3010667733-2024-00566
• Device Sequence Number: 18234967
• Product Code: HRS
• UDI-Device Identifier: 00840420126511
• UDI-Public: 00840420126511
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120359
• 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,Followup
• Report Date (Section B): 10/24/2024

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 Catalogue Number: 587111RT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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