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	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: the complaint device was received and inspected.The complaint can be confirmed.The device was received with the thumb screw which fixates the femoral guide to the guide frame broken off.It was reported that the thumb screw broke off when it was impacted with a mallet during the procedure.The thumb screw is not meant to be impacted with the mallet, therefore the root cause for the reported failure can be attributed to user mishandling.No lot numbers were supplied which precludes conducting a device history record (dhr) review.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.Udi: (b)(4)-incomplete.The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during an acl reconstruction procedure the sales rep's rigidfix femoral guide frame thumb screw was being tapped with a mallet when it broke off from the device.The sales rep stated that the breakage occurred outside of the patient and therefore nothing fell into the patient cavity.The case was completed with this device, as there was a tight fit so no additional issues arose.There was no patient harm or time delay.The sales rep could not provide a lot number.The device is being returned for evaluation.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8369804
• Report Number: 1221934-2019-56490
• Device Sequence Number: 1057761
• Product Code: LXH
• UDI-Device Identifier: 10886705002955
• UDI-Public: 10886705002955
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/26/2019
• Patient Sequence Number: 1