MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR 9.5MM *EA; ARTHROSCOPIC DRAINAGE CANNULA

Model Number	219410
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Udi: (b)(4).
Event or Problem 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.
Additional 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.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: 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 [19j01] 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: a manufacturing record evaluation was performed for the finished device [19j01] number, and no non-conformances were identified.

• Common Device Name: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9624260
• Report Number: 1221934-2020-00290
• Device Sequence Number: 2738811
• Product Code: NBH
• UDI-Device Identifier: 10886705006359
• UDI-Public: 10886705006359
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 219410
• Device Catalogue Number: 219410
• Device Lot Number: 19J01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1