MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE FISH MOUTH TIP 2.9MM INLINE; ACCESSORIES,ARTHROSCOPIC

Model Number 72201389

Device Problem Failure to Advance (2524)

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

Event Date 05/23/2018

Event Type  malfunction  

Event Description

It was reported that sales representative noticed that there is a friction point and drill bit will not slide through drill guide.No back up device was available.No patient injury was reported.

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.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting: the event was reported because there was no back up device available during the procedure, however per communication with the sales representative, it was confirmed that there was a smith and nephew back up device available to complete the procedure succesfully therefore the reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: GUIDE FISH MOUTH TIP 2.9MM INLINE
• 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: 7727939
• MDR Text Key: 115467685
• Report Number: 1219602-2018-00953
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010595522
• UDI-Public: (01)03596010595522(10)50572382
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2018

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 Model Number: 72201389
• Device Catalogue Number: 72201389
• Device Lot Number: 50572382
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 08/27/2018
• Supplement Dates FDA Received: 08/09/2018; 08/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2015
• 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