MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC SALVATION¿ MIDFOOT NAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT,

Catalog Number	SMN10008
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The midfoot nail was successfully attached to the connector and implanted.The surgeon felt the handle "snap" on his final turn.It was then realized the connector nipples/wings broke off and the connector was removed from the nail.The surgeon could not retrieve the small metal fragments.The surgeon successfully compressed the nail and closed without issues.
Additional Manufacturer Narrative
Device return is expected.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination shows that the tab for orientation is broken off and were not returned.Furthermore, the fracture surface finds evidence of a ductile overload fracture resulting from excessive force.Moreover the returned devices finds normal wear and tear consistent with reusable devices.The current instrument instructions for use state: "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling", "inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure", and "the useful life of these devices depends on many factors, including the method and duration of each use and the handling between uses".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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by ductile overload fracture resulting from excessive force.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The midfoot nail was successfully attached to the connector and implanted.The surgeon felt the handle "snap" on his final turn.It was then realized the connector nipples/wings broke off and the connector was removed from the nail.The surgeon could not retrieve the small metal fragments.The surgeon successfully compressed the nail and closed without issues.

• Brand Name: SALVATION¿ MIDFOOT NAIL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT,
• 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: 13338174
• Report Number: 3010667733-2022-00026
• Device Sequence Number: 17509278
• Product Code: LXH
• UDI-Device Identifier: 00840420194817
• UDI-Public: 00840420194817
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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 Catalogue Number: SMN10008
• Device Lot Number: 2519306
• 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: 12/27/2021
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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