MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 16MMCORT; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW TM,SS 3.5X 16MMCORT
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2022
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
On (b)(6) 2022, it was reported by a sales representative via email that an ar-2652cr clavicle fracture plate was implanted in patient on (b)(6) 2022 during a clavicle fracture.Patient felt the plate break and on (b)(6) 2022, it was confirm via x-rays that the plate had broken.A revision surgery has been schedule by the same surgeon that performed the original procedure and it will take place at the same facility.This revision surgery has been scheduled for (b)(6) 2022 to remove all the implanted screws along with the broken plate.Additional information received on 5/26/2022: during original procedure, surgeon implanted the following: one ar-2652cr clavicle fracture plate, one ar-2665-16h fragment screw, one ar-2665-18h fragment screw, one ar-2665-20h fragment screw, one ar-2665-22h fragment screw, one ar-8835-16 low profile screw, one ar-8835-18 low profile screw, two ar-8835-20 low profile screws, one ar-8835l-16 low profile locking screw, and three ar-8835l-18 low profile locking screw.All these implants were removed during revision surgery on (b)(6) 2022.Case was completed successfully using synthes without further issues.
Additional Manufacturer Narrative
Complaint not confirmed.Upon visual inspection it was noted that there was slight wear to the threads and the hexalobe.The damage to the threads and hexalobe can most likely be contributed to implantation/explanation of the device.Measurement of the device shows that the devices meet design specifications.No allegation was made against this device.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Common Device Name: SCREW, 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: 14675312
• Report Number: 1220246-2022-05071
• Device Sequence Number: 5084328
• Product Code: HWC
• UDI-Device Identifier: 00888867047297
• UDI-Public: 00888867047297
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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 SCRW TM,SS 3.5X 16MMCORT
• Device Catalogue Number: AR-8835-16
• Device Lot Number: 14087773
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown