MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICROGRASPER STRAIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number 7207598

Device Problem Bent (1059)

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

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

One 7207598 straight micrograsper returned.This is a three year old reusable device.The complaint stated: ¿it was reported that the device was bent.¿ the device condition indicates aggressive use.The front end shaft is visibly bowed and bent toward the left.The jaw still bites tightly.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.This instrument is not intended to have excessive force applied when manipulating soft tissue, bone, or hard objects.Misuse of the instrument may result in instrument failure.No root cause related to the manufacture of the device was established.

Event Description

It was reported that the device was bent.No back-up device was available.No patient injury reported.

Manufacturer Narrative

The complaint stated: ¿it was reported that the device was bent.¿ the device condition indicates aggressive use.The front end shaft is visibly bowed and bent toward the left.The jaw still bites tightly.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument, since excessive force can result in instrument failure.This instrument is not intended to have excessive force applied when manipulating soft tissue, bone, or hard objects.Misuse of the instrument may result in instrument failure.No root cause related to the manufacture of the device was established.

• Brand Name: MICROGRASPER STRAIGHT
• 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: 7589248
• MDR Text Key: 111013531
• Report Number: 1219602-2018-00716
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010427311
• UDI-Public: (01)03596010427311(10)50535246
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

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: 7207598
• Device Catalogue Number: 7207598
• Device Lot Number: 50535246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 06/11/2018
• Supplement Dates FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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