MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; IMPACTOR

Catalog Number	906-0006
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contaminant matter was discovered inside the cannula of an instrument in the field, as the product was not satisfactorily inspected and decontaminated.Capa-2024-0027 has been opened to address this issue.
Event or Problem Description
As instruments were unpacked by spd, two instruments were seen to be contaminated.The stem impactor had apparent human bone fragments stuck inside the threading of the central column.Additionally, the drill guide sheath had rust or another contaminant inside the cannula.The result was a 2-hour surgical delay as the instruments were washed twice in succession to make sure they were thoroughly cleaned.Capa 2024-0027 has been opened to address this issue.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: IMPACTOR
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer Contact: tristan mahler ; 15920 addison road; addison, TX 75001 ; 7137326920
• MDR Report Key: 19214386
• Report Number: 3014128390-2024-00024
• Device Sequence Number: 18191361
• Product Code: LXH
• UDI-Device Identifier: 03701037312308
• UDI-Public: 03701037312308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 906-0006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART: 951-0023 LOT: T2480
• Patient Sex: Unknown