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); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

It was reported that the drill tip broke during procedure and the fragment could not be removed.A backup device was available.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.

Manufacturer Narrative

One 2.6mm bioraptor 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 were found to meet print specifications.Drill was tested for material condition and confirmed to meet the (b)(4) specification (b)(4) actual was (b)(4) ).Drill is nearly seven years old and shows normal wear.This investigation could not identify any evidence of product contribution to the reported complaint.

• 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: 7037326
• MDR Text Key: 92192748
• Report Number: 1219602-2017-01424
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2018

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 Catalogue Number: 72201108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 01/24/2018; 09/19/2018
• Supplement Dates FDA Received: 01/31/2018; 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other