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

Catalog Number	AR-1386
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/25/2018
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 received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the driver's distal tip was broken-off.There were gouging and grip mark damages noted on the distal end of the shaft's surface.The device met all material specifications as received.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 additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the ar-1380b broke, then the ar-1390b, then the screwdriver broke.The tip of the screw driver remained in the patient.The fragments of the screws were removed.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SCREWDRIVER,CANNULATED 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: 7285128
• Report Number: 1220246-2018-00052
• Device Sequence Number: 1993986
• 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: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 351705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/21/2018
• 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-1380B, BIO-INTERFERENCE SCREW, LOT 10137168; AR-1390B, BIO-INTERFERENCE SCREW, LOT 10025109
• Outcome Attributed to Adverse Event: Other