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	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4)-incomplete.The lot number is currently unavailable.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.There is evidence that the device has been heavily used, as indicated by the numerous striations across the surface and faded laser lines.It is possible that the screw was excessively tightened on the guide frame causing fatigue and eventually breaking it, especially if the device is already worn and heavily used.However, given the information provided we cannot discern a definitive root cause for the reported failure.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 that during an acl procedure, it was observed that ther rigidfix thumbscrew device broke while in use with the 0mm rigidfix femoral rod device.They opened another tray to complete the procedure.It was not reported if there was a delay in the surgical procedure.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.
Additional Manufacturer Narrative
Awareness date reported on initial report as july 18, 2018 but should have been november 06, 2018.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8074285
• Report Number: 1221934-2018-55317
• Device Sequence Number: 11195755
• Product Code: LXH
• UDI-Device Identifier: 10886705002962
• UDI-Public: 10886705002962
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/18/2018

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: 08/15/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1