MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD 9.5MM *EA; BONENAIL GUIDEWIRE

Model Number	213719
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: according to the information provided, it was reported that two blind devices were received in decontamination site on 12/09/2020 with no complaint information attached and could not be associated with an existing complaint.The devices 213207 (bone tendon bone guide) and 213719 (rigidfix femrod 9.5mm *ea) were received and evaluated.When performing the visual inspection, it could be observed that both devices are attached one to the other and cannot be separated.The lock screw that keeps attached the rigidfix rod with the bone guide was found to be broken, a little portion of the screw remains inside the locking point, therefore the devices cannot be separated.The broken lock knob was not returned.No other anomalies were found.Since this is a reusable device, this failure possibly occurred after hard and rough use for many procedures leading to a lock screw breakage.However, this cannot be conclusive determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.
Event or Problem Description
It was reported that during decontamination, it was observed that the device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the lock screw that attaches the rigidfix rod with the bone guide was found to be broken that a little portion of the screw remained inside the locking point; and therefore the devices could not be separated.There was no procedure involved.No additional information was provided.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11065253
• Report Number: 1221934-2020-04047
• Device Sequence Number: 11822470
• Product Code: FZX
• UDI-Device Identifier: 10886705003105
• UDI-Public: 10886705003105
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2020

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: 213719
• Device Catalogue Number: 213719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1