MAUDE Adverse Event Report: ARTHREX, INC. COMPRESSION FT SCREW, 3.5 MINI, 34 MM LENGTH; SCREW, FIXATION, BONE

Catalog Number	AR-8730-34H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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.No device malfunction identified and at this time it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was discarded.Additional event information has not been made available.Device history record review revealed nothing relevant to this event.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.Device reported to have been discarded.
Event or Problem Description
It was reported that during an orif left foot navicular procedure, the surgeon was inserting an ar-8730-34h, 3.5 mini compression ft screw 34 mm length.Upon insertion, the last 8 mm of the screw broke.The remaining 26 mm of the screw was left in the navicular as it was across the fracture plane and reported to be secure.A second mini compression screw of the same part and lot number was opened and used to complete the case.

• Brand Name: COMPRESSION FT SCREW, 3.5 MINI, 34 MM LENGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6442782
• Report Number: 1220246-2017-00100
• Device Sequence Number: 19208144
• Product Code: HWC
• UDI-Device Identifier: 00888867127067
• UDI-Public: 00888867127067
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K132217
• 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
• Report Date (Section B): 03/29/2017

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-8730-34H
• Device Lot Number: 10056718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/29/2017
• 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
• Patient Age: 18 YR