MAUDE Adverse Event Report: SYNTHES USA AIMING ARM FOR SUPRAPATELLAR

Catalog Number 03.010.441

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2012

Event Type  malfunction  

Event Description

It was reported that the outer protection sleeve came off the handle during usage, and one screw did not advance into the hole.This 2 of 3 report for complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The part was not returned for evaluation.The lot number is unknown; therefore, a review of the device history record could not be completed.No conclusion could be drawn, as the part was not received.Placeholder.

• Brand Name: AIMING ARM FOR SUPRAPATELLAR
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3798395
• MDR Text Key: 4526118
• Report Number: 2520274-2014-01005
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• PMA/PMN Number: K111667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR