MAUDE Adverse Event Report: ARTHREX, INC. HEADLESS COMPRESSION SCREW; SCREW, FIXATION, BONE

Catalog Number	AR-8625-34
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2016
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.Lot number not provided therefore device history review cannot be performed.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.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during the hallux valgus surgery, the screw broke-off on insertion.The broken part was retained in the patient.The surgery was finished sucessfully with a new screw of same type.No further information available.
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.Lot number not provided therefore device history review cannot be performed.Complaint confirmed.The device met all material specifications as received.The evaluation of the returned device revealed a torsional break at the threads on the distal end of screw.The complainant's event is typically caused by the use of excessive force in conjunction with improper bone preparation.
Event or Problem Description
It was reported that during the hallux valgus surgery, the screw broke-off on insertion.The broken part was retained in the patient.The surgery was finished successfully with a new screw of same type.No further information available.

• Brand Name: HEADLESS COMPRESSION SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6073166
• Report Number: 1220246-2016-00471
• Device Sequence Number: 16162138
• Product Code: HWC
• UDI-Device Identifier: 00888867125704
• UDI-Public: 00888867125704
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132217
• 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): 11/29/2016

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-8625-34
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 12/01/2016
• 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