MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE LOCKING SCREW 3.5 MM X 34 MM; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE LOCKING SCREW 3.5 MM X 34 MM
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
On 11/30/2022, it was reported by an arthrex employee via email that an ar-8935l-34s low profile locking screw package did not have the patient's label included.This was discovered during a procedure on (b)(6) 2022.Additional information requested.

• Brand Name: LOW PROFILE LOCKING SCREW 3.5 MM X 34 MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19380750
• Report Number: 1220246-2024-03708
• Device Sequence Number: 7688991
• Product Code: HWC
• UDI-Device Identifier: 00888867051065
• UDI-Public: 00888867051065
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: LOW PROFILE LOCKING SCREW 3.5 MM X 34 MM
• Device Catalogue Number: AR-8935L-34S
• Device Lot Number: 14934252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown