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

Catalog Number	AR-1997
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2017
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.The device was requested and is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.This type of event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation or flexing the joint during insertion.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the screwdriver broke at the level of the screw head where the screw is normally inserted.The central core of the screwdriver is completely buried in the screw and not removable.The surgery was completed successfully.
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 due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the device's hex was broken.The device met all material specifications as received.This type of event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation or flexing the joint during insertion.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the screwdriver broke at the level of the screw head where the screw is normally inserted.The central core of the screwdriver is completely buried in the screw and not removable.The surgery was completed successfully.

• Brand Name: SCREWDRIVER SFT,CANN,FOR BIO-INTERFERENCE. SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6958024
• Report Number: 1220246-2017-00377
• Device Sequence Number: 13651869
• Product Code: LXH
• UDI-Device Identifier: 00888867025738
• UDI-Public: 00888867025738
• 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: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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-1997
• Device Lot Number: 10066509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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