MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, CANNULATED, 8.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72203164

Device Problem Stretched (1601)

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

Event Type  malfunction  

Event Description

It was reported that sa was drilling femoral tunnel.She had just entered the femoral tunnel in forward full speed and was moving the drill slowly.She stopped drill to read the depth off of reamer.The surgeon noticed that the distal tip of reamer between tip and flexible shaft was being stretched.The surgeon commented, "once you start to drill, its going to snap again." and, that's exactly what happened.This is the second flexible reamer to snap in past six weeks.We went through all checkpoints of possible reasons for this and concluded it had to be an issue with the reamer.The reamer has only been used less than 5 times.A kelly was used to remove pieces and a backup device was available to complete the procedure with no significant delay or 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.No further investigation is required.

Event Description

It was reported that sa was drilling femoral tunnel.She had just entered the femoral tunnel in forward full speed and was moving the drill slowly.She stopped drill to read the depth off of reamer.The surgeon noticed that the distal tip of reamer between tip and flexible shaft was being stretched.The surgeon commented, "once you start to drill, its going to snap again." and, that's exactly what happened.They went through all checkpoints of possible reasons for this and concluded it had to be an issue with the reamer.No patient injuries were reported but it is unknown if there was a delay or a backup device available to complete the procedure.Attempts were made to retrieve further information but no response was received from the complainant.

• Brand Name: DRILL, FLEXIBLE, CANNULATED, 8.5MM
• 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: 8193056
• MDR Text Key: 131375133
• Report Number: 1219602-2018-01770
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010654571
• UDI-Public: 03596010654571
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

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: 72203164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/22/2018
• Supplement Dates Manufacturer Received: 02/08/2019
• Supplement Dates FDA Received: 02/11/2019
• 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: Unknown
• Patient Sequence Number: 1