MAUDE Adverse Event Report: ARTHREX INC. WRIST DRILL GUIDE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-8816G
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/24/2018
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.This is one of two submissions from the same event.The other is (b)(4).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 drill sleeve was not well fixed into the drill guide.The drill sleeve's outside diameter was within specification.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 drill sleeve is not well fixed into the device.It does not spin during drilling.Because of that incident the surgeon had to switch the surgical technique from an "trans-osseous discus re-fixation" to an " trans-scapular discus re-fixation".There was no harm for patient, user or third party.

• Brand Name: WRIST DRILL GUIDE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7341122
• Report Number: 1220246-2018-00092
• Device Sequence Number: 1052235
• Product Code: MDM
• UDI-Device Identifier: 00888867259904
• UDI-Public: 00888867259904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/15/2018

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-8816G
• Device Lot Number: 1448175101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/15/2018
• 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