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

Catalog Number	213702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4)-incomplete.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.Visual observation indicates the thumbscrew was broken.The femoral rod is stuck inside the guide frame and cannot be separated.The sales rep reported the complaint device is over five years old and has seen heavy use.The likely root cause for the reported problem is the surgeon inadvertently struck the thumbscrew while malleting out the guide frame from the patient, resulting in the thumbscrew breaking.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.
Event or Problem Description
It was reported by the sales rep via phone that post to an acl procedure the thumb screw on the customer's rigidfix femoral btb guide frame broke off and they were unable to remove the rod from inside of the device.During in-house engineering evaluation, it was determined that the thumbscrew was broken.The sales rep confirmed that nothing fell or broke in the patient.The procedure had been completed with the device prior to the issue occurring with no patient harm or delays to the case.The sales rep could not provide a lot number for the device but stated that the device is over five years old and has seen heavy use in the field.The device will be returning for evaluation.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: 8199068
• Report Number: 1221934-2018-55853
• Device Sequence Number: 19320839
• Product Code: LXH
• UDI-Device Identifier: 10886705002962
• UDI-Public: 10886705002962
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/26/2018

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: 213702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1