MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PP INTRAFIX ADVANCE SHEATH, LARGE 30 MM; 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)
Date of Event	04/17/2018
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) -incomplete.The expiration date is currently unavailable.
Event or Problem Description
It was reported by the sales rep that the label on the their large 30 mm intrafix advance sheath was blue when the color should be purple prior to an acl procedure.The case was completed with another like device.There were no patient consequences or delays.The sales rep provided a picture and the device will not be returned.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Investigation summary = > the complaint device is not being returned and is therefore unavailable for a physical evaluation.Pictures were provided which have been analyzed to confirm the complaint.A non-conformance search was performed for this part/lot combination and two non-conformances were identified.According to the investigation, there is a non-medical impact to the device as the intrafix advance system instrumentation and implants are color coded by size.This issue may cause difficulty in identifying the correct size sheath.Functionality of the product is not impacted by this issue.Depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: PP INTRAFIX ADVANCE SHEATH, LARGE 30 MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle 2400 ; SZ 2400
• MDR Report Key: 7502776
• Report Number: 1221934-2018-50617
• Device Sequence Number: 16188936
• Product Code: MBI
• UDI-Device Identifier: 10886705027538
• UDI-Public: 10886705027538
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Followup
• Report Date (Section B): 04/17/2018

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: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 254826
• Device Lot Number: L434132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1