MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL HEX BUTTON; BOLT NUT WASHER

Model Number 400-783

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device remains implanted in the patient, and is not available for evaluation.A dhr review was conducted, and confirms that the device met manufacturing specification prior to shipping from rti surgical.The customer confirmed that there has been no patient effect.There are no plans to revise at this time.This report will be updated should additional information become available at a later date.

Event Description

It was reported to rti surgical on (b)(6) 2020 that an expired hex button implant had been implanted.The product expired on 3/26/2020, and approximately 2.5 months later (175 days) it was implanted on (b)(6) 2020.

• Brand Name: PIONEER SURGICAL HEX BUTTON
• Type of Device: BOLT NUT WASHER
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 10714520
• MDR Text Key: 212508580
• Report Number: 1833824-2020-00081
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2020
• Device Model Number: 400-783
• Device Catalogue Number: N/A
• Device Lot Number: 56614243
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other