ARM SLEEVE CONNECTOR, S3

Additional Manufacturer Narrative

AFTER EVALUATION OF THE UNIT, ALLEN MEDICAL BECOME AWARE OF A POTENTIAL PROBLEM WITH THE ARTHREX S3 ARM SLEEVE CONNECTOR (AR-1650-02) MANUFACTURED AND DISTRIBUTED BETWEEN MARCH AND NOVEMBER OF 2016. DURING USE, THERE IS A POTENTIAL SCENARIO WHICH COULD ALLOW THE UNIT TO SEPARATE UN-EXPECTANTLY. THIS FAILURE WOULD ALLOW THE PATIENTS ARM TO FALL OUT OF SUSPENSION DURING A PROCEDURE, POSSIBLY CAUSING MODERATE INJURY TO THE PATIENT. THIS POTENTIAL DEFECT IS NOT APPARENT TO THE USER AND NO INJURIES HAVE BEEN REPORTED. AFFECTED PARTS WERE REDESIGNED TO ELIMINATE THE POSSIBILITY OF SEPARATION. THE ASSEMBLY DESIGN AND INSTRUCTIONS HAVE BEEN UPDATED TO REFLECT THE CHANGE. THE CORRECTIVE ACTION TO ADDRESS THIS SITUATION IN THE FIELD WAS TO OBTAIN ALL UNITS FROM THE FIELD, EVALUATE FOR THE DEFECT, AND REPLACE ALL DEFECTIVE UNITS.

Description of Event or Problem

THE PINS FROM THE SLEEVE CONNECTOR FELL OUT DURING A LABRAL REPAIR. THE PATIENT'S ARM DROPPED AS A RESULT OF THE PINS COMING OUT. ACCORDING TO THE CLINICAL MANAGER AT THE SITE, THE EVENT TOOK PLACE EARLY IN THE CASE, PRIOR TO ANCHOR PLACEMENT, AND THERE WAS NO INJURY WITH THIS EVENT. THE PROCEDURE WAS COMPLETED IN STANDARD FASHION, SWITCHING TO THEIR OLD LATERAL TRACTION BOOM.

Additional Manufacturer Narrative

AWAITING THE RETURN OF THE FAILED DEVICE FOR ROOT CAUSE EVALUATION, REMEDIATION DETERMINATION AND IMPLEMENTATION. A FOLLOW-UP MDR WILL BE FILLED.

Description of Event or Problem

THE PINS FROM THE SLEEVE CONNECTOR FELL OUT DURING A LABRAL REPAIR. THE PATIENT'S ARM DROPPED AS A RESULT OF THE PINS COMING OUT. ACCORDING TO THE CLINICAL MANAGER AT THE SITE, THE EVENT TOOK PLACE EARLY IN THE CASE, PRIOR TO ANCHOR PLACEMENT, AND THERE WAS NO INJURY WITH THIS EVENT. THE PROCEDURE WAS COMPLETED IN STANDARD FASHION, SWITCHING TO THEIR OLD LATERAL TRACTION BOOM.