MAUDE Adverse Event Report: ARTHREX INC. PARTIAL ECLIPSE DRILL GUIDE/SIZER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-2820
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
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.The device was requested/is expected for evaluation but has not yet been received.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the guidance jig snapped at what looks like the weld point when the surgeon was lining up the patient's anatomy.Upon closer inspection it looks like the jig was already bent and damaged.No broken fragment remained inside the patient.The performed surgery was a partial eclipse.The surgery was completed successfully with a different device: ac tightrope aiming jig.The surgeon also had to adapt the technique using a jig that was not set at the correct angle as it was they had on the shelf.There was no harm for patient, user or third party.
Event or Problem Description
It was reported that the guidance jig snapped at what looks like the weld point when the surgeon was lining up the patients anatomy.Upon closer inspection it looks like the jig was already bent and damaged.No broken fragment remained inside the patient.The performed surgery was a partial eclipse.The surgery was completed successfully with a different device: ac tightrope aiming jig.The surgeon also had to adapt the technique using a jig that was not set at the correct angle as it was they had on the shelf.There was no harm for patient, user or third party.
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.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed a broken weld between the target cup and the arm guide.However, the exact cause cannot be determined.Complainant's event is typically caused by excessive bending forces being applied during use.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

• Brand Name: PARTIAL ECLIPSE DRILL GUIDE/SIZER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7521500
• Report Number: 1220246-2018-00188
• Device Sequence Number: 11122525
• Product Code: MDM
• UDI-Device Identifier: 00888867027862
• UDI-Public: 00888867027862
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/19/2018

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-2820
• Device Lot Number: 021040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2018
• Supplement Date Received by Manufacturer: 04/28/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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