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

Model Number	LO-PRO SCRW TM,SS 3.5X 16MMCORT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the following devices were implanted on the (b)(6) 2023: ar-2652cl (lot: 5262102); ar-8835l-16 (lot: 14975878); ar-8835l-18 (lot: 14975879), ar-8835-16 (lot: 14999011) and ar-8835-18 (lot: 14983034).The plate bent post-op without external influence.On the (b)(6) 2023, it was removed and replaced with a new clavicle fracture plate (ar-2652cl).No further information received.
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.
Additional Manufacturer Narrative
Complaint is not confirmed.Upon visual and dimensional evaluation, there was no problem with the screws.No problem found.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 16904837
• Report Number: 1220246-2023-06696
• Device Sequence Number: 12472116
• Product Code: HWC
• UDI-Device Identifier: 00888867047297
• UDI-Public: 00888867047297
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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?: Yes
• 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: 14999011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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