MAUDE Adverse Event Report: CORELINK, LLC TIGER MIS; TIGER MIS ROD REDUCER

Model Number 3000-120

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

As the device was not returned for inspection, it was unable to be inspected.Additionally, the lot number of the device was not provided, so production records were unable to be reviewed for the device.A historical review was conducted, and it was found that there has never been a complaint filed for this reported issue.As limited information was provided, no further investigation was able to be completed.This complaint has been logged to assist in trending.

Event Description

The customer initially reported that one of the tips of the devices broke off during reduction.Later, upon a review of intra-operative and post-operative images, it was discovered that a piece of the device remained in the surgical site.A revision surgery was performed to retrieve the piece and it was reported that this surgery was successful.

• Brand Name: TIGER MIS
• Type of Device: TIGER MIS ROD REDUCER
• Manufacturer (Section D): CORELINK, LLC; 2072 fenton logistics park; fenton MO 63026
• Manufacturer Contact: allison meyer ; 2072 fenton logistics park; fenton, MO 63026 ; 8883497808
• MDR Report Key: 12513762
• MDR Text Key: 272739826
• Report Number: 3006494201-2021-00006
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3000-120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1