MAUDE Adverse Event Report: CONMED PLATE SCREW, Ø2.4 X 16 MM, NON-LOCKING; SCREW, FIXATION, BONE

Catalog Number	P62 ST416
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The conmed representative reported on behalf of the customer that the p62 st416 plate screw, ø2.4 x 16 mm, non-locking device was being used during a 5ms procedure on (b)(6) 2025 when it was reported ¿an expired implant was implanted on (b)(6) 2025.The implant was p62 st416 lot number gm000944.The expiration date on the product was (b)(6) 2025.The product was removed from the patient on (b)(6) 2025 by the surgeon as the hospital noticed the expiration date after the device was placed in the patient.The procedure was completed with the use of the same alternate device.This report is being raised on the reported injury due to the patient requiring an additional operation.
Additional Manufacturer Narrative
The device will not be returned for evaluation; however, the device history record label and the surgery date have been provided.Root cause cannot be determined; however, a possible cause of this event could be that the labeling was not inspected prior to use.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of one device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4) we will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The conmed representative reported on behalf of the customer that the p62 st416 plate screw, ø2.4 x 16 mm, non-locking device was being used during a 5ms procedure on (b)(6) 2025 when it was reported ¿an expired implant was implanted on (b)(6) 2025.The implant was p62 st416 lot number gm000944.The expiration date on the product was 27-october-2025.The product was removed from the patient on (b)(6) 2025 by the surgeon as the hospital noticed the expiration date after the device was placed in the patient.The procedure was completed with the use of the same alternate device.This report is being raised on the reported injury due to the patient requiring an additional operation.

• Brand Name: PLATE SCREW, Ø2.4 X 16 MM, NON-LOCKING
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• Manufacturer (Section G): IN2BONES USA, LLC; 7750a trinity rd; cordova TN 38018
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 23988442
• Report Number: 3011580264-2026-00001
• Device Sequence Number: 4694761
• Product Code: HWC
• UDI-Device Identifier: 00817906022148
• UDI-Public: (01)00817906022148(17)251027(10)GM00944
• Combination Product (Y/N): N
• PMA/510(K) Number: K170518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Expiration Date: 10/27/2025
• Device Catalogue Number: P62 ST416
• Device Lot Number: GM000944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic