MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE CLANCY FLEXIBLE DRIL; DRILL, FLEXIBLE, ENDOSCPC, 4.5

Model Number 72202971

Device Problem Material Fragmentation (1261)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The surgeon had just completed reaming with a larger clancy reamer (size unsure) to facilitate proper tunnel width for the graft insertion.The surgeon then chose to ream with the 4.5mm clancy flexible reamer from within the notch over the existing 2.4mm flexible passing pin to break through the outer femoral cortex to facilitate passage of the endobutton.This was done through an anteromedial portal.While reaming, the reamer snapped at roughly mid shaft.The shaft portion of the reamer was easily removed over the 2.4mm flexible passing pin from the am portal, however the remaining tip portion of the reamer was removed with a pair of tweezers thru a new incision.Upon inspection, the reamer had already exited the outer cortex, so no additional reaming or replacement was necessary at this point in the procedure.

Manufacturer Narrative

One drill, flexible, endoscpc, cann, 4.5mm was returned for evaluation of the reported complaint mode, ¿broken¿.The reported complaint was confirmed.The drill was received in two pieces; the drill had a clean break at two spirals on one side of the drill.The pin appears to have been rubbing against the drill internal diameter at the location of the break.The drill is bent in a way that is consistent with over-bending of the drill.A review of the device history records was performed which confirmed no inconsistencies.There were no internal processing issues which could have contributed to the nature of the complaint.(b)(4).

• Brand Name: CLANCY FLEXIBLE DRIL
• Type of Device: DRILL, FLEXIBLE, ENDOSCPC, 4.5
• Manufacturer (Section D): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3999143
• MDR Text Key: 4704873
• Report Number: 1219602-2014-00236
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50503234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1