MAUDE Adverse Event Report: ARTHREX, INC. ACL GUIDE FRAME HANDLE ASS'Y; MANUAL INSTR, GENERAL SURGICAL

Model Number	ACL GUIDE FRAME HANDLE ASS'Y
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder prothesis surgery the 3mm drill was passed through the drill sleeve and the devices then cold-welded.This resulted in abrasion.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.Update kpilz 30-aug-2024: the abrasion did not enter the patient.Update kpilz 16-sep-2024: the handle is worn at the interface to the reduction sleeve.The customer provided the information on the (b)(6) 2024 that the handle was used during the same surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1510h serial/batch number (b)(6) was received for evaluation.Visual inspection revealed heavy that the drill slot sleeve is missing the anodized color.Also, abrasion was noted inside the slot, and marks around the device were noted.The most likely cause of the reported failure is user error, caused by overstressing a device that is damaged naturally and inevitably due to normal wear or aging.

• Brand Name: ACL GUIDE FRAME HANDLE ASS'Y
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 20248952
• Report Number: 1220246-2024-07720
• Device Sequence Number: 17964900
• Product Code: MDM
• UDI-Device Identifier: 00888867018372
• UDI-Public: (01)00888867018372(11)160615(10)43211604
• 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): 01/09/2025

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: ACL GUIDE FRAME HANDLE ASS'Y
• Device Catalogue Number: AR-1510H
• Device Lot Number: 43211604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown