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

Model Number	AC GUIDE, RIGHT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the head of the device broke off during an acromio clavicular dislocation surgery.The broken piece was retrieved from the patient's body.According to the reporter, the surgical technique had to be changed but no details were given what had to be changed and the following was reported: "unusable material has to be replaced by another system whose secondary ablation will be necessary".Update 22-june-2020: the following information has been made available today: it was impossible to put on the endo-button, so the surgeon put a pin to hold the collarbone in place in front of the scapular.The surgery took approx.30 - 45 min longer than expected due to this incident.
Additional Manufacturer Narrative
Complaint confirmed, the head detached after the weld broke.The bent pins suggests the head was bent.A likely cause of the event is prying/leveraging the device.

• 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: 10217860
• Report Number: 1220246-2020-01935
• Device Sequence Number: 2404220
• 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: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other