MAUDE Adverse Event Report: ARTHREX, INC. 2.7MM SCREW DEPTH INDICATOR; DEPTH GAUGE

Model Number	2.7MM SCREW DEPTH INDICATOR
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
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 length measurement did not work properly and therefore wrong screws were chosen.There was no harm for patient, operator or third party reported.No further information received.***update 13-sep-2023 nroe: further information revealed that this incident occurred during a clavicle fracture treatment with a distal clavicle plate.There was no harm for patient, operator or third party.The surgery was finished successfully after replacing the screws that were to long with shorter screws.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-2670 batch 1068642103 was received for evaluation.Upon visual evaluation, the measuring needle tip was bent.Wear and tear were also observed.Measurement of the instrument's overall length by drawing c11016 at revision 3 found the device out of tolerance due to the bent on the tip.No functional test was performed due to the damage to the device.This event is most likely caused by misuse by prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: 2.7MM SCREW DEPTH INDICATOR
• Common Device Name: DEPTH GAUGE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17864205
• Report Number: 1220246-2023-08060
• Device Sequence Number: 14998315
• Product Code: HTJ
• UDI-Device Identifier: 00888867098534
• UDI-Public: 00888867098534
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 2.7MM SCREW DEPTH INDICATOR
• Device Catalogue Number: AR-2670
• Device Lot Number: 1068642103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown