MAUDE Adverse Event Report: TRIMED INC K-WIRE 1.1, 100MM

Model Number	WIRE-1.1/100
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trimed inc ((b)(4)) plans to send the correct labels to trimed (b)(4) where trimed (b)(4) will take off the incorrect label and replace with the appropriate label.Trimed (b)(4) is trimed inc in (b)(4) importer/ distributor for europe.
Event or Problem Description
Trimed (b)(4) (an importer / distributor for trimed inc) stated on (b)(6) 2021 that 150 (30 tubes of 5 each) wire-1.1/100 devices were labeled for the wire-0.7/080.This is product mislabeled.

• Brand Name: K-WIRE 1.1, 100MM
• Common Device Name: K-WIRE 1.1, 100MM
• Manufacturer (Section D): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: stephanie rissler ; 27533 avenue hopkins; santa clarita, CA 91355 ; 6612557406
• MDR Report Key: 12682014
• Report Number: 2031009-2021-00005
• Device Sequence Number: 3572283
• Product Code: NDL
• UDI-Device Identifier: 00842188109331
• UDI-Public: 00842188109331
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K951303
• 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: Relabeling
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: Other
• Device Model Number: WIRE-1.1/100
• Device Catalogue Number: WIRE-1.1/100
• Device Lot Number: 90598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown