MAUDE Adverse Event Report: 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 32; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	212.112
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: jds.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date, during an unknown procedure, the surgeon commented that the distal fibula plate was too bulky and decided to remove it in exchange for a 1/3 tubular plate on the fibula.While using a 1/3 tubular on the medial side of the tibia, the surgeon could not get the locking mechanism to function, however, it was possible that the locking hole was deformed by putting a previous non-locking screw.There was no surgical delay.The procedure was successfully completed.There were no patient consequences.This report is for one (1) 3.5 lckng screw slf-tpng w/sd(tm) rec 32.This is report 3 of 3 for (b)(4).

• Brand Name: 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 32
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• MDR Report Key: 12719760
• Report Number: 2939274-2021-06378
• Device Sequence Number: 11769254
• Product Code: KTT
• UDI-Device Identifier: 10886982151865
• UDI-Public: 10886982151865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: 212.112
• Device Catalogue Number: 212.112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7/3.5 LCP LATERAL DSTL FIB PL 4H/RT/86; LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57
• Patient Weight: 113