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

Model Number	AC GUIDE, RIGHT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed, the head was found to be detached from the body of the device.Investigation revealed the filet weld broke and the pins and pin holes were deformed.The most likely cause is prying and/or leveraging the device during use.
Event or Problem Description
It was reported that the device broke.The extremity dissociated from the rest of the viewfinder when it was put in place for arthroscopic acromioclavicular dysjunction intervention.Broken piece was retrieved from patient.No harm for patient, operator or third party was reported.The surgery was finished successfully.Update 28-aug-2019: surgeon had to change surgical technique.The planned technique was arthroscopic acromio clavicular dysjunction.Because of the incident, the surgeon had to change his intervention to an open procedure.

• Brand Name: AC GUIDE, RIGHT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9081026
• Report Number: 1220246-2019-01318
• Device Sequence Number: 3643235
• Product Code: MDM
• UDI-Device Identifier: 00888867026247
• UDI-Public: 00888867026247
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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 Model Number: AC GUIDE, RIGHT
• Device Catalogue Number: AR-2254R
• Device Lot Number: 25301146
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other