MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX TIB GDEFR *EA; GUIDE

Model Number	213800
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
It was reported that post-operatively to an unknown procedure on an unknown date in 2019, the thumb screw on the customer's rigidfix tibial guide frame broke off causing the rigid tibial rod 10mm to become stuck together with the guide.This occurred during cleaning of the device.It was noted that the devices are over ten years old and have seen heavy use in the field.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Investigation summary : the complaint device was received and inspected.Visual observation reveals the thumb screw was broken and the femoral rod is stuck inside the guide frame, confirming this complaint.It is possible that the screw was excessively tightened during procedure causing it to snap.Other than this possibility, we cannot discern a root cause for this failure.The device appears to be old and is in worn condition.This failure can be attributed to fair wear and tear.Furthermore, no lot number was supplied which precludes conducting a manufacturing record evaluation.At this point in time, 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).The lot number is unknown.

• Common Device Name: GUIDE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9321519
• Report Number: 1221934-2019-59522
• Device Sequence Number: 2524780
• Product Code: FZX
• UDI-Device Identifier: 10886705003136
• UDI-Public: (01)10886705003136
• 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): 10/18/2019

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 Model Number: 213800
• Device Catalogue Number: 213800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/17/2019
• Patient Sequence Number: 1