MAUDE Adverse Event Report: TRIMED INC CANNCOMPSCREW 3.0MM (SELFDRILL)

Model Number	L3034
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been inspected and is within trimed's specifications.
Event or Problem Description
A trimed sales representative reported on 30 mar 2021 that the l3034 that was implanted in patient (b)(6) on (b)(6) 2020 had to be removed.The screw was causing some pain in the bottom of the patient's foot which led to the screw being removed.It was reported that the patient was fully healed from the initial surgery in september but the screw had migrated from its original location causing the pain.It was also stated that the surgeon used a countersink under power in the original surgery, likely causing the screw to migrate.Trimed surgical instruments lc-73-0004-014-usa rev f states, "trimed driver shafts, countersinks and taps must be connected to a hand-held, manually operated handle, and are not advised to be placed under power equipment.".

• Brand Name: CANNCOMPSCREW 3.0MM (SELFDRILL)
• Common Device Name: CANNCOMPSCREW 3.0MM (SELFDRILL)
• Manufacturer (Section D): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 11735009
• Report Number: 2031009-2021-00002
• Device Sequence Number: 3832796
• Product Code: HWC
• UDI-Device Identifier: 00842188103209
• UDI-Public: 00842188103209
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: L3034
• Device Catalogue Number: L3034
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR