MAUDE Adverse Event Report: ARTHREX INC. SCREWDRIVER,CANN FOR BIO INT. SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-1386
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
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.The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Complainant's event typically caused by continually applying torque after the screw is fully seated, torquing when the implant is not properly aligned and/or torquing while leveraging the device.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the tip of the screwdriver broke inside the bioabsorbable screw.The broken fragment was not removed but remained inside the screw and was fixed there.The surgery was completed successfully, no negative consequences for the patient have been reported so far.It was not necessary to switch the surgical technique or do a second surgery.Follow-up investigation: an x-ray was done, but no computerized picture is available.The transplant is blocked in the femur tunnel with the screw.The surgeon was not able to give more information.The part number of the screw is ar-1370b with batch no.10169107.
Event or Problem Description
It was reported that the tip of the screwdriver broke inside the bioabsorable screw.The broken fragment was not removed but remained inside the screw and was fixed there.The surgery was completed successfully, no negative consequences for the patient have been reported so far.It was not necessary to switch the surgical technique or do a second surgery.Follow-up investigation: an x-ray was done, but no computerized picture is available.The transplant is blocked in the femur tunnel with the screw.The surgeon was not able to give more information.The part number of the screw is ar-1370b with batch no.10169107.
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.Complaint confirmed.The driver met dimensional and material specification.Visual evaluation revealed the driver was received with the hexed tip of the driver broken off the shaft.The broken distal end was not received for evaluation.Complainant's event typically caused when the joint is flexed during insertion of the implant with the driver engaged or prying/leveraging of the driver.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

• Brand Name: SCREWDRIVER,CANN FOR BIO INT. SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7577715
• Report Number: 1220246-2018-00211
• Device Sequence Number: 2364703
• Product Code: LXH
• UDI-Device Identifier: 00888867015425
• UDI-Public: 00888867015425
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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-1386
• Device Lot Number: 401010514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other