MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL,UNIV.ENDO.CANN 5.0MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7208686

Device Problem Sticking (1597)

Patient Problem Burn(s) (1757)

Event Date 10/27/2017

Event Type  Injury  

Event Description

It was reported that a chaser got stuck in the drill.When the device was pulled out for its extraction caused a burn to the patient at the level of the opening way of the chaser.

Manufacturer Narrative

One 5mm cannulated endoscopic drill was returned for evaluation.Visual assessment of the drill showed no evidence of heating up.Dimensional assessment of the drill confirmed it meets print specification.This investigation could not identify any evidence of product contribution to the reported complaint.Further investigation is not warranted at this time.

• Brand Name: DRILL,UNIV.ENDO.CANN 5.0MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 7023054
• MDR Text Key: 91755443
• Report Number: 1219602-2017-01384
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7208686
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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