MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC CONMED ORTHO LINVATEC BEATH PIN ANATOMIC ACL KIT; PIN, FIXATION, SMOOTH

Catalog Number 8820

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2019

Event Type  Injury  

Event Description

Pin fragment, retained in pt's thigh.Fda safety report id# (b)(4).

• Brand Name: CONMED ORTHO LINVATEC BEATH PIN ANATOMIC ACL KIT
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC
• MDR Report Key: 9286071
• MDR Text Key: 165553042
• Report Number: MW5090906
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 8820
• Device Lot Number: 1036515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 66