MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM GDEFR S/T *EA; BONENAIL GUIDEWIRE

Catalog Number	213701
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2016
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 tested visually.Metal plates on the device were inspected to see if there were any metal scrapings or burrs.There appears to be some burrs on one of the grooves under the metal plate.The frame was inspected for straightness and no anomalies were found.The striations on the groove indicating the fit between the sleeves and the guide frame were not tight.It is possible the screw was not tightened all the way on the metal plate of the guide frame or was loosened during the use.This failure can be attributed to user technique.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the affiliate in (b)(6) that during a left anterior cruciate ligament acl reconstruction soft tissue surgical procedure, during use of the 'rigidfix soft tissue guide' instrument to place the single use trocars from a 'rigidfix femoral st cross pin kit' via drill power, it was observed that the guide and trocar have cold welded together.The surgeon was unable to advance the trocar into the appropriate position.There was no harm caused to the patient.There was visual damage noted to the instrument and trocar.The guide and trocar were removed and a second 'rigidfix soft tissue guide' instrument and 'rigidfix femoral st cross pin kit' were opened and used successfully to complete the case.There was a delay in the surgical procedure of 10 minutes.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: 8282082
• Report Number: 1221934-2018-52230
• Device Sequence Number: 11371294
• Product Code: LXH
• UDI-Device Identifier: 10886705002955
• UDI-Public: 10886705002955
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 08/11/2016

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: 213701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2016
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1