MAUDE Adverse Event Report: ARTHREX, INC. 2.7/3.0/3.5/4.0MM DEPTH GUIDE, 100MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2.7/3.0/3.5/4.0MM DEPTH GUIDE, 100MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that a ar-8963-01 depth guide mis measured.This occurred on (b)(6) 2022 during a pilon fx when reviewing the final xray it was found that the screws lengths were much shorter than the measurement of the depth gauge.The screws were removed and remeasured with a different depth gauge.There was no additional information provided.Additional information provided on 10/19/2022, it was reported that additional anesthesia was administered due to the 15 minute delay.A working depth gauge was brought in to complete the case.The gauge was measuring 10mm short for every screw length.When the depth gauge is measuring at the 10mm you can't see the metal end.
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 confirmed.One unpackaged ar-8963-01, batch number: 012043, was received for investigation.Functional testing cannot be performed because of the bend.The instrument was bent previously received for the investigation.Visual evaluation found that the needle is bent and doesn't let the slider move freely.The observed event is most likely caused by excessive bending forces applied during use.

• Brand Name: 2.7/3.0/3.5/4.0MM DEPTH GUIDE, 100MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15743538
• Report Number: 1220246-2022-05708
• Device Sequence Number: 5851001
• Product Code: LXH
• UDI-Device Identifier: 00888867229341
• UDI-Public: 00888867229341
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2.7/3.0/3.5/4.0MM DEPTH GUIDE, 100MM
• Device Catalogue Number: AR-8963-01
• Device Lot Number: 012043
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown