MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT; GTR IMPLANT SET, EXT 4-H,W/CABLE,STERILE

Model Number	401-084
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Expiration Date Error (2528); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and is not available for evaluation.A dhr review was conducted and confirms the device met manufacturing specification prior to shipping from rti surgical facility.This report will be updated should information become available at a later date.
Event or Problem Description
"the sap system has informed us that 1 expired product has been consumed in a surgery when the product was being invoicing.The product expired on 16.09.2021 and was used in a surgery on (b)(6) 2021.Neither impact in patient nor claim or incidence has been informed.".
Event or Problem Description
Our distribution partner, zimmer biomet, reported that "the sap system has informed us that 1 expired product has been consumed in a surgery when the product was being invoicing.The product expired on 16.09.2021 and was used in a surgery on (b)(6) 2021.Neither impact in patient nor claim or incidence has been informed.".

• Brand Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Common Device Name: GTR IMPLANT SET, EXT 4-H,W/CABLE,STERILE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: joshua penrose ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 13454264
• Report Number: 1833824-2022-00015
• Device Sequence Number: 4675315
• Product Code: KTT
• UDI-Device Identifier: 00846468064068
• UDI-Public: (01)00846468064068(17)210916(10)56653395
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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 Expiration Date: 09/16/2021
• Device Model Number: 401-084
• Device Lot Number: 56653395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown