MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, ENDOSCPC, CANN, 5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202972

Device Problem Break (1069)

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

Event Date 12/18/2018

Event Type  malfunction  

Event Description

It was reported that during surgery the device broke when it was milling with the drill.It is unknown if the pieces were retrieved from the patient.A backup device was available to complete the procedure with no significant delay and no patient injuries.

Manufacturer Narrative

Additional information.

Event Description

It was reported that during an acl surgery the device broke when it was milling with the drill.All the pieces were removed from the patient.A backup device was available to complete the procedure with no significant delay and no patient injuries.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.

• Brand Name: DRILL, FLEXIBLE, ENDOSCPC, CANN, 5MM
• 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 ; 5123585706
• MDR Report Key: 8194077
• MDR Text Key: 131342618
• Report Number: 1219602-2018-01778
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: 03596010654533
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202972
• Device Lot Number: 50559238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 12/24/2018
• Supplement Dates Manufacturer Received: 01/09/2019; 02/04/2019
• Supplement Dates FDA Received: 01/10/2019; 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27 YR