MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR 12.0MM *EA; ARTHROSCOPIC DRAINAGE CANNULA

Model Number 219415

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It was reported that by affiliate via complaint submission tool, that during control in the warehouse, a total of eight (8) tunnel dilator (7.5 mm, 9.5 mm, 12.0 mm, 10.5 mm, 6.5 mm, 11.5 mm, 8.5 mm, 6.0 mm) presented residue in the cavity.The devices were new.No surgical delay or patient consequence reported.

Manufacturer Narrative

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary
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> according to the information provided, it was reported that during control in the warehouse, a total of eight (8) tunnel dilator (7.5 mm, 9.5 mm, 12.0 mm, 10.5 mm, 6.5 mm, 11.5 mm, 8.5 mm, 6.0 mm) presented residue in the cavity.The devices were new.The complaint devices were received and evaluated.Visual observation confirms that tunnel dilators and plastic bags didn¿t present any kind of residue or foreign material as reported by customer since the devices are new.At this point, we cannot discern a possible root cause for defect reported due to the devices went submitted to a decontamination process before they arrive at destination for analysis, it is possible that the residue reported could be lost during mentioned process.A manufacturing record evaluation was performed for the finished device [15n01] number, and no non-conformances were identified.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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [15n01] number, and no non-conformances were identified.

• Type of Device: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9624584
• MDR Text Key: 200439347
• Report Number: 1221934-2020-00291
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705006403
• UDI-Public: 10886705006403
• 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: 01/14/2020

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: 219415
• Device Catalogue Number: 219415
• Device Lot Number: 15N01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/21/2020
• Patient Sequence Number: 1