MAUDE Adverse Event Report: ARTHREX, INC. 2.8MM CANNULATED DRILL GUIDE, MEDIUM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	2.8MM CANNULATED DRILL GUIDE, MEDIUM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
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 during a shoulder surgery the central wire no longer fit through the middle opening of the device.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully by inserting the wire hands free.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the central cannulation of the drill guide had circumferential abrasions on the interior of the device.A pin gage inspection was performed per drawing c9788 requirements.This test failed on the higher end of the tolerance and it was noted that the pin was catching against the abrasion.Probable cause is attributed to wear and tear damage based on the age and returned condition of the device.

• Brand Name: 2.8MM CANNULATED DRILL GUIDE, MEDIUM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 14976415
• Report Number: 1220246-2022-05198
• Device Sequence Number: 5073533
• Product Code: MDM
• UDI-Device Identifier: 00888867192607
• UDI-Public: 00888867192607
• 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): 08/31/2022

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: 2.8MM CANNULATED DRILL GUIDE, MEDIUM
• Device Catalogue Number: AR-9215-4CG
• Device Lot Number: 051642
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown