MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO STR PLT,3.0MM5 HOLE,TI; PLATE, FIXATION, BONE

Model Number	LO-PRO STR PLT,3.0MM5 HOLE,TI
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the device was removed from the patient.The original date of surgery was (b)(6) 2020 for a r mrj fusion; per the reporter the removal was voluntary.No more information was given.
Additional Manufacturer Narrative
Complain not confirmed as no allegations were provided.It is unknown why the plate was explanted.The plate was found to be bent and the locking threads were damaged.6 screws were returned with damaged threads and drive features.

• Brand Name: LO-PRO STR PLT,3.0MM5 HOLE,TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11947271
• Report Number: 1220246-2021-03217
• Device Sequence Number: 4420736
• Product Code: HRS
• UDI-Device Identifier: 00888867055049
• UDI-Public: 00888867055049
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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 Model Number: LO-PRO STR PLT,3.0MM5 HOLE,TI
• Device Catalogue Number: AR-8952TS-05
• Device Lot Number: 5261927
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown