MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR 11.5MM *EA; ARTHROSCOPIC DRAINAGE CANNULA

Model Number 219414

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Initial reporter is synthes sales representative.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

It was reported that there is a quality problem of equipment number (b)(4), tunnel dilators sizes 6mm-10.5mm.They present the elimination of oxide after sterilization.The products are consigned in the client.This complaint involves thirteen devices.This (b)(4) captures three devices while the linked (b)(4) captures remaining ten devices.This is report 2 of 3 for (b)(4).

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.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, multiple attempts for obtaining additional information and for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.Historically, this type of damage to the product has been due to a non-neutral ph solution being used in the cleaning process, which does not follow the cleaning and sterilization instructions contained with the mitek instrument instructions for use.However, no further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained in the future, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, 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).The lot number is unknown.

• Type of Device: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8570153
• MDR Text Key: 145774287
• Report Number: 1221934-2019-56968
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705006397
• UDI-Public: (01)10886705006397
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

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
• Device Operator: Health Professional
• Device Model Number: 219414
• Device Catalogue Number: 219414
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 05/30/2019
• Patient Sequence Number: 1