MAUDE Adverse Event Report: ARTHREX, INC. CORACOID DRILL GUIDE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	CORACOID DRILL GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
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
On 17-oct-2022, it was reported by a sales rep via email that a ar-7000-07, coracoid drill guide handle clasp was broken.This was discovered during use and a case was involved.To complete the procedure, the instrument was used manually by holding onto handles to support guide whilst drilling.Drill was broken when sent into hospital.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation of the picture attached to the complaint of an ar-7000-07 coracoid drill guide.It was noted that the clasp mechanism was broken/detached at the weld.Laser marks faded.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

• Brand Name: CORACOID DRILL GUIDE
• 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: 15698553
• Report Number: 1220246-2022-05690
• Device Sequence Number: 20881139
• Product Code: MDM
• UDI-Device Identifier: 00888867040854
• UDI-Public: 00888867040854
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 06/03/2024

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: CORACOID DRILL GUIDE
• Device Catalogue Number: AR-7000-07
• Device Lot Number: 45552048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown