MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 6MM CANNULATED; BIT, DRILL

Model Number	DRILL, 6MM CANNULATED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/29/2021, it was reported by a facility representative via sems that a ar-9216-3 glenoid drill and a ar-9215-4cgpp pin guide were damaged.This occurred on (b)(6) 2021 during an eclipse tsa when the guide bent the pin , and the bent pin damaged the drill.All fragments were retrieved.The case was completed successfully by proceeding with a standard procedure.There was no patient effect reported.
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 confirmed.One unpackaged ar-9216-3 was received for investigation.Visual inspection identified breakage across the distal end of the flutes.As such, the dimensions of the flute geometry could not be accurately assessed.The observed condition is consistent with the allegation of a damaged pin interfering with the drill during use detailed within the event description.The cause of the pin damage remains undetermined.

• Brand Name: DRILL, 6MM CANNULATED
• Common Device Name: BIT, DRILL
• 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: 13569679
• Report Number: 1220246-2022-04494
• Device Sequence Number: 6136883
• Product Code: HTW
• UDI-Device Identifier: 00888867192621
• UDI-Public: 00888867192621
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/08/2022

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: DRILL, 6MM CANNULATED
• Device Catalogue Number: AR-9216-3
• Device Lot Number: 021615
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown