MAUDE Adverse Event Report: ARTHREX, INC. STEPPED, RATCHET DRILL SLEEVE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	STEPPED, RATCHET DRILL SLEEVE
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The 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 the surgery the cap came loose from the shaft.There was no harm for the patient, operator or third party.It was not necessary to switch the surgical technique.Update (b)(6) 2018: a meniscal root surgery was performed.Additional information was received that the surgery was not completed successfully because during this surgery the sleeve did not stay in place.It slid off the mark every time they tried to drill.There was no second device available during the surgery.Because of this incident, a second surgery will be necessary.They do not have a date for the second surgery as yet.
Additional Manufacturer Narrative
The complaint was confirmed.Examination of the device shows the base is loose and rotates freely around the sleeve.It is also loose enough to be pulled back without effort about 5mm, and can be completely removed from the device with little effort.Visual inspection of the base shows no sign of damage.Signs of light wear can be seen on the bottom surface likely due to other objects hitting and rubbing on that surface.The most likely cause is excessive torque applied to the device leading to the weld failure and spinning of the sleeve/base.
Additional Manufacturer Narrative
The complaint was confirmed that the sleeve broke off from the distal knob.Most likely cause of the event is due to the device failure and as stated in the event description not following surgical technique causing misalignment of device assembly.

• Brand Name: STEPPED, RATCHET DRILL SLEEVE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8209086
• Report Number: 1220246-2019-00823
• Device Sequence Number: 2027413
• Product Code: MDM
• UDI-Device Identifier: 00888867196766
• UDI-Public: 00888867196766
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: STEPPED, RATCHET DRILL SLEEVE
• Device Catalogue Number: AR-1510FS-7
• Device Lot Number: 151750
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 12/18/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/15/2019; 03/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other