MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE FLUTED DRILL; 2.5MM FLUTED DRILL W/ DEPTH STOP

Model Number 72202890

Device Problem Material Fragmentation (1261)

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

Event Date 12/09/2013

Event Type  malfunction  

Event Description

During a hip arthroscopy utilizing the 2.5mm fluted drill w/ depth stop it was reported that the drill broke.The broken piece was removed with a grasper.Customer inquired as to how many times a drill can be used.No device is returning for analysis.Additional hole needed to be drilled.

Manufacturer Narrative

(b)(4): no product is being returned for analysis.(b)(4).

Manufacturer Narrative

Supplemental report being completed to add device lot number and date of manufacture of the device.(b)(4).

Manufacturer Narrative

Evaluation was not possible, as the device will not be returned.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review has not identified additional complaints for this lot number on file.There were no internal processing issues which could have contributed to the nature of the complaint.Due to these facts we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.(b)(4).

• Brand Name: FLUTED DRILL
• Type of Device: 2.5MM FLUTED DRILL W/ DEPTH STOP
• 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: jason bilobram ; 150 minuteman road; andover, MA 01810 ; 9787491630
• MDR Report Key: 3549997
• MDR Text Key: 20360139
• Report Number: 1219602-2014-00002
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202890
• Device Catalogue Number: 72202890
• Device Lot Number: 50476397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2013
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2013
• 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