MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE DRILL, BIORAPTOR; DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC

Model Number 72201108

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

During a labrum repair in the shoulder, it was reported that the tip of the drill broke at the hub inside the patient¿s bone.After a 2.3mm anchor was inserted, it was noticed that the tip was still inside the drilled hole within bone.An x-ray was done to confirm the piece was present.A 2.9mm anchor was also used without further incident.The patient¿s post-op condition was reported as fine.Clarification from the sales rep.States that an mri was performed several days post-op and the broken tip of the drill was not in the bone but in the soft tissue of the patient¿s right shoulder.The patient will be rescheduled for additional procedure to remove the broken tip.The customer has retained the drill; however, a picture of the device was taken and will be forwarded to be included in the complaint file.

Manufacturer Narrative

The customer has retained the device therefore, no evaluation is possible.(b)(4).

Manufacturer Narrative

A device was not returned for evaluation.However the reporter was able to provide a picture of the complaint device.It was reviewed and confirmed to be broken, as the cutting edges were not attached to the shaft of the device.However due the quality of the picture it is difficult to determine the exact nature and location of the break.A review of the manufacturing records identified that the device was manufactured april 2008, and no issues were identified during manufacture.No further analysis could be performed therefore a conclusion regarding root cause could not be made.(b)(4).

• Brand Name: DRILL, BIORAPTOR
• Type of Device: DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC
• 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: 3774124
• MDR Text Key: 4374204
• Report Number: 1219602-2014-00135
• 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,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/28/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201108
• Device Catalogue Number: 72201108
• Device Lot Number: 50250189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2014
• Device Age: 6 YR
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2008
• 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
• Patient Outcome(s): Other