MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE TUNNEL NOTCHER *EA; TENDON/LIGAMENT TUNNELLER

Catalog Number	219351
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received inside the sterilization case that was originally reported to us as a complaint.The melted plastic that was observed inside the case was also found on this device.It is possible that the user mistakenly placed an object inside the sterilization case that cannot withstand the reprocessing conditions that the sterilization case requires for proper reprocessing.Therefore, the conditions caused the plastic part to melt and contact the device.No actual device defect was observed.No lot numbers were supplied which precludes conducting a device history record (dhr) review.At this point, 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.(b)(4).The lot number is currently not available.
Event or Problem Description
It was reported by the sales representative that it looks like some plastic material was left inside tray container and melted in a small pool at the bottom of the tray when it was autoclaved.There was no patient consequence.All the information being submitted for this complaint all the details that are known/available regarding this event.

• Common Device Name: TENDON/LIGAMENT TUNNELLER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8253117
• Report Number: 1221934-2019-56010
• Device Sequence Number: 11301417
• Product Code: NBH
• UDI-Device Identifier: 10886705005932
• UDI-Public: 10886705005932
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 219351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/16/2019
• Patient Sequence Number: 1