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

Catalog Number	213701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2013
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: evaluation statement - the complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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.(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate that during an unknown procedure thumbscrew broke: rigidfix screw broke while tightening the rod into the rigidfix femoral guide frame.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8322878
• Report Number: 1221934-2019-56365
• Device Sequence Number: 11287759
• Product Code: LXH
• UDI-Device Identifier: 10886705002955
• UDI-Public: 10886705002955
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 12/10/2013

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2013
• Initial Report FDA Received Date: 02/08/2019
• Patient Sequence Number: 1