MAUDE Adverse Event Report: ARTHREX INC. DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	AR-3600D
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/27/2017
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.Lot number was not provided so device history record review cannot be performed.The device was requested/is expected but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.The most likely cause(s) of this type of event include prying and/or leveraging on the device during use or mechanical damage to the device, such as dropping or hitting the device with another device prior to use.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 during a bristow bankart procedure under arthroscopy, a surgeon drilled a bone hole and attempted to insert the anchor, but the anchor stopped in the middle of the bone hole.He drilled the bone hole again and noticed that the tip of the drill was damaged.The tip of the drill remained in the bone hole.The broken tip remained in the patient.Follow-up investigation the reported confirmed that the drill tip remained in the bone hole/tunnel.Reporter has no additional information with regard to whether an anchor was later placed in the tunnel, thus securing the drill tip or not.Reporter also had no additional information with regard to how the procedure was completed after the drill tip broke.
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 was not provided so device history record review cannot be performed.Complaint confirmed.The evaluation revealed that the device distal tip was broken-off.The device met all material specifications as received.The most likely cause(s) of this type of event include prying and/or leveraging on the device during use or mechanical damage to the device, such as dropping or hitting the device with another device prior to use.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 during a bristow bankart procedure under arthroscopy, a surgeon drilled a bone hole and attempted to insert the anchor, but the anchor stopped in the middle of the bone hole.He drilled the bone hole again and noticed that the tip of the drill was damaged.The tip of the drill remained in the bone hole.The broken tip remained in the patient.Follow-up investigation: the reported confirmed that the drill tip remained in the bone hole/tunnel.Reporter has no additional information with regard to whether an anchor was later placed in the tunnel, thus securing the drill tip or not.Reporter also had no additional information with regard to how the procedure was completed after the drill tip broke.

• Brand Name: DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7185385
• Report Number: 1220246-2017-00516
• Device Sequence Number: 19188733
• Product Code: HWE
• UDI-Device Identifier: 00888867239128
• UDI-Public: 00888867239128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/18/2018

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-3600D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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