MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC IMPLANT HOLDER ASSEMBLY SALVATION MIDFOOT NAIL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	SMN10008
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the midfoot nail adapter broke off during the procedure.The piece that broke was still attached to the midfoot nail.When removing the midfoot nail holder from the midfoot nail after implantation, that is when it was noted that the item broke.Debris was retained in the im canal of the metatarsal.It did not impact anything and the surgeon was not concerned with it.
Additional Manufacturer Narrative
Correction - h6 (results code).The complaint could be confirmed, since the information for evaluation matches the alleged failure.The investigation revealed the following: an inspection of the image has shown that the alignment pin is broken of from the implant holder as reported.For further statement it's needed that we receive the product back for investigation.The current instructions for use state: "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling.Care must be taken to avoid compromising their exacting performance." 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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.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 midfoot nail adapter broke off during the procedure.The piece that broke was still attached to the midfoot nail.When removing the midfoot nail holder from the midfoot nail after implantation, that is when it was noted that the item broke.Debris was retained in the im canal of the metatarsal.It did not impact anything and the surgeon was not concerned with it.

• Brand Name: IMPLANT HOLDER ASSEMBLY SALVATION MIDFOOT NAIL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 19639154
• Report Number: 3010667733-2024-00409
• Device Sequence Number: 12535822
• Product Code: MDM
• UDI-Device Identifier: 00840420194817
• UDI-Public: 00840420194817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/08/2024

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: SMN10008
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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