MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201108

Device Problems Break (1069); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 11/17/2017

Event Type  Injury  

Event Description

It was reported that while drilling into the bone, the distal tip of the drill broke where the cylinder shaft portion and the actual drill tip connect.The broken piece was stuck deep in the bone and was unable to be retrieved.The patient had to be transported over to the main hospital for further evaluation.The drill was able to be removed after another open procedure at the main hospital.

Manufacturer Narrative

One 2.6mm spade tip drill with depth stop was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.The entire drill head has broken off and was not returned for examination.The break shows no material voids.Dimensional inspection of all attributes of the drill that could be measured was found to meet print specifications.Drill was tested for material condition and confirmed to meet the rockwell specification.Drill is nearly nine years old and shows wear.Without the return of the broken drill head a root cause cannot be determined.

• Brand Name: DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7085204
• MDR Text Key: 93804123
• Report Number: 1219602-2017-01517
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72201108
• Device Lot Number: 50278786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2008
• 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): Required Intervention