MAUDE Adverse Event Report: ARTHREX, INC. STEP DRILL, FOR 3.0MM KNOTLESS SUTURE TAK; BIT, DRILL

Catalog Number AR-1938D

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This is one of two submissions from the same patient event.The other is 1220246-2017-00024 (cc104986 line 181874).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.The evaluation of the returned devices revealed metal gouges.Further evaluation revealed that the two returned drill's are bent.Device history record review revealed nothing relevant to this event.The most likely cause of this type of event include excessive bending force applied to the 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.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that two 2.6mm drills for 3mm suturetak (ar-1938d) along with one 3mm suturetak percutaneous insertion kit (cc104986 line181875 ar-1934pi-30) and one trocar tip obturator for 3mm suturetak disposable spear (cc104986 line 181877 ar-1949s) were being used in a shoulder labral repair procedure.While using the first drill (cc104986 line 181872) with a competitors device set at full speed along with the drill guide from ar-1934pi-30 (cc104986 line 181875), it was noticed that there were metal shavings being produced inside the patient.An attempt was made to remove the metal shavings from the patient by using a frazier tip suction device and high flow shaver.The surgeon was unable to retrieve all shavings.The second drill (cc104986 line181874) was used with a competitors device, along with the disposable spear (cc104986 line 181877) and also produced metal shavings.The same technique was used again to try and remove the metal shavings, and again all of the shavings were unable to be retrieved from the patient.Sales rep stated the surgeon mentioned that she believes the metal shavings were created by the drill and drill guide coming in contact with each other.A reusable drill guide and a new drill bit with a competitors device were used to complete the procedure successfully.

• Brand Name: STEP DRILL, FOR 3.0MM KNOTLESS SUTURE TAK
• Type of Device: 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, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6338830
• MDR Text Key: 67709085
• Report Number: 1220246-2017-00023
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888867024212
• UDI-Public: 00888867024212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: AR-1938D
• Device Lot Number: 10064485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AR-1934PL-30 LOT 10021315 PERC INSERT KIT; AR-1949S LOT 432576 FASTAK II SPEAR W/TROCAR
• Patient Outcome(s): Other