MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS HUMELOCK REVERSED SHOULDER; INSTRUMENT

Catalog Number	903-0102
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When checking the instrumentation into the hospital for a case on (b)(6) 2024, the sterilization officer pulled two t handles from the kit for contamination.The sterilization officer believed the contaminant to be blood or bioburden.Based on a review of provided photos, the contaminant is likely rust.Regardless, the parts were cleaned to the hospital's standards before check in was finalized.No surgical delay occurred as the case the instrumentation was for had already been rescheduled for unrelated reasons.Capa-2024-0027 has been opened to address this issue.
Additional Manufacturer Narrative
Contaminant matter was discovered inside the cannulas 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.

• Brand Name: HUMELOCK REVERSED SHOULDER
• Common Device Name: INSTRUMENT
• 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: 19315591
• Report Number: 3014128390-2024-00028
• Device Sequence Number: 15181179
• Product Code: LXH
• UDI-Device Identifier: 03701037306185
• UDI-Public: 03701037306185
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 903-0102
• Device Lot Number: K916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/14/2024
• 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: 903-0102 LOT: UNK
• Patient Sex: Unknown