MAUDE Adverse Event Report: ARTHREX INC. ARTHREX DISPOSABLES KIT, TRANSTIBIA ACL WITHOUT BLADE; PIN FIXATION SMOOTH

Model Number	AR-1898S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) y/o female underwent left knee anterior cruciate ligament reconstruction to repair left acl tear.Arthrex transtibial guide pin utilized during procedure.Post op knee x-ray completed with finding of retained piece of the tibial guide pin.Pt required admission overnight as had eaten post operatively and need to wait an add'l 6 hrs prior to surgical removal.Pt underwent successful removal of guide pin on (b)(6) 2018 to prevent any complications related to the retention of guide pin.

• Brand Name: ARTHREX DISPOSABLES KIT, TRANSTIBIA ACL WITHOUT BLADE
• Common Device Name: PIN FIXATION SMOOTH
• Manufacturer (Section D): ARTHREX INC. ; naples FL 34108
• MDR Report Key: 7673490
• Report Number: MW5078301
• Device Sequence Number: 1384436
• Product Code: HSB
• UDI-Device Identifier: 00888867022461
• UDI-Public: (01)00888867022461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR-1898S
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2018
• 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: 26 YR