MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRAFX ADV POLYPROSHTHLG 30MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254826
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: 1221934-2018-50681.
Event or Problem Description
It was reported by the sales rep while checking his trunk stock that he received two of the large 30 mm intrafix advance sheath with a blue label instead of purple from the same lot number.

• Brand Name: INTRAFX ADV POLYPROSHTHLG 30MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7523866
• Report Number: 1221934-2018-50683
• Device Sequence Number: 11056752
• Product Code: MBI
• UDI-Device Identifier: 10886705027538
• UDI-Public: 10886705027538
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: No Information
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 254826
• Device Lot Number: L434132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1