MAUDE Adverse Event Report: DEPUY MITEK LLC US TRACKER SLOPESELECT ARM *EA; BONENAIL GUIDEWIRE

Catalog Number	219455
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The lot number is currently unavailable.The complaint device was received and evaluated.The reported failure could be confirmed from the visible marks on the drill and it was bent where it had cold welded with the cannula.Since the drill was bent it would not spin freely inside of the cannula which would cause this failure.Historically, this type of failure has been attributed to user technique issue.The bent drill is spinning within the cannula causing enough heat and friction to cause the "welding" of the two parts.Batch reviews were not conducted as the batch numbers of the devices are unknown.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.This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that during a knee repair surgical procedure, it was observed that his cortical screw, 4.5mmx 42mm became stripped when the surgeon was inserting it into very hard bone.The sales rep reported that the surgeon had tapped when prepping the bone hole.The sales rep reported that his tracker slope select arm and his tracker drill bit also became cold welded during the procedure.The surgeon completed the procedure with another like device in the same bone hole with no patient consequences.There was a 25 minute delay in the procedure.The sales rep could not provide the lot numbers for the devices.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8241492
• Report Number: 1221934-2018-50976
• Device Sequence Number: 11158739
• Product Code: NBH
• UDI-Device Identifier: 10886705006571
• UDI-Public: 10886705006571
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2015

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: 219455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2015
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1