MAUDE Adverse Event Report: DEPUY MITEK MILAGRO ADVANCE TAP, 9-10MM; BONE TAP, REUSABLE

Catalog Number	219497
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint device was received and visually inspected.Visual observation confirms a portion of the cleaning brush is broken and stuck inside the distal end of the tap.This complaint can be confirmed.The rest of the returned brush was bent in multiple spots.A possible root cause is that the brush¿s shaft was bent in the middle of pre-sterilization, resulting in it snapping and breaking.This failure is attributed to user mishandling.There were no additional anomalies with the returned tap.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other similar complaints from this lot of devices.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.(b)(4).This report is being filed from the remetrex 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 post to an anterior cruciate ligament (acl) surgical procedure, while cleaning the inside of the milagro advance tap, 9-10mm device, it was observed that a piece of the brush that was being used to clean the device became stuck within the device.It was reported that when they tried to use a guidewire to remove the piece of brush, the guidewire also became stuck in the cannula of the tap; and were unable to remove the pieces that were stuck in the cannula of the tap.It was reported that the surgeon completed the procedure with the device with no patient consequences or delays.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: MILAGRO ADVANCE TAP, 9-10MM
• Common Device Name: BONE TAP, REUSABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7757972
• Report Number: 1221934-2018-54080
• Device Sequence Number: 16583602
• Product Code: LXH
• UDI-Device Identifier: 10886705023165
• UDI-Public: 10886705023165
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2015

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: 219497
• Device Lot Number: 1212002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2015
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1