MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT FOR 3.5MM SWIVELOCK; BIT, DRILL

Model Number	DRILL BIT FOR 3.5MM SWIVELOCK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
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.
Event or Problem Description
It was reported that during a swivelock elbow surgery while drilling the elbow the device broke off.It was further reported that a drill guide was used.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed, the tip broke off about 18 mm from the distal end.Circumferential scuff marks were observed along the shaft.The device was found to meet dimensional and material specifications.The cause is undetermined, however the damaged observed suggest a likely cause of the event is prying/leveraging the device during use.

• Brand Name: DRILL BIT FOR 3.5MM SWIVELOCK
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11258799
• Report Number: 1220246-2021-02519
• Device Sequence Number: 17200754
• Product Code: HTW
• UDI-Device Identifier: 00888867020863
• UDI-Public: 00888867020863
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRILL BIT FOR 3.5MM SWIVELOCK
• Device Catalogue Number: AR-1678-05
• Device Lot Number: 04511942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other