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

Catalog Number	AR-1510FS-7
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.No device malfunction identified in accordance with 21cfr 803.3, section 2.14.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The most likely cause(s) of this type of event include prying and/or leveraging on the device during use or mechanical damage to the device, such as dropping or hitting the device with another device during use.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.
Event or Problem Description
It was reported that a stepped ratchet drill sleeve, ar-1510fs-7, lot 051520 ((b)(4)), was being used in an acl soft tissue autograft procedure.After the procedure, the device was sterilized and returned to the distributor's office.Upon return to the distributor, it was noted that the tip of the drill sleeve had a chip missing from it.During the procedure a flip cutter ar-1204as-75, lot 530659980 ((b)(4)) was being used and spinning at full force when drilling the femoral tunnel.Sales rep states the chip appears almost to have been burned out, possibly by the flip cutter.It is unknown if the broken piece may have remained in the patient since the chip was not noticed until after the procedure, after sterilization and after return to the distributor office.The case was completed successfully with a composite screw on the tibia.No patient injury reported.Flip cutter will not be returned as it was discarded after surgery.Update (b)(6) 2016: sales rep confirmed with surgeon that patient has had no issues to date and no follow up x-rays have been taken.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission for device evaluation.Complaint confirmed.The evaluation revealed that a portion of the device's distal tip is chipped off.The tip's edge is dented diagonally from the chipped area.Additionally, gouges and scratches were observed on the drill sleeve.The device met all material specification as received.Complainant's event is typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.
Event or Problem Description
It was reported that a stepped ratchet drill sleeve, ar-1510fs-7 lot 051520 ((b)(4)), was being used in an acl soft tissue autograft procedure.After the procedure, the device was sterilized and returned to the distributor's office.Upon return to the distributor, it was noted that the tip of the drill sleeve had a chip missing from it.During the procedure a flip cutter ar-1204as-75 lot 530659980 ((b)(4)) was being used and spinning at full force when drilling the femoral tunnel.Sales rep states the chip appears almost to have been burned out, possibly by the flip cutter.It is unknown if the broken piece may have remained in the patient since the chip was not noticed until after the procedure, after sterilization and after return to the distributor office.The case was completed successfully with a composite screw on the tibia.No patient injury reported.Flip cutter will not be returned as it was discarded after surgery.Update 9/14/16: sales rep confirmed with surgeon that patient has had no issues to date and no follow up x-rays have been taken.

• 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: 5953209
• Report Number: 1220246-2016-00384
• Device Sequence Number: 10871271
• Product Code: MDM
• UDI-Device Identifier: 00888867196766
• UDI-Public: 00888867196766
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2016

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 Catalogue Number: AR-1510FS-7
• Device Lot Number: 051520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 09/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-1204AS-75, FLIPCUTTER II, SHORT, LOT 530659980
• Outcome Attributed to Adverse Event: Other