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

Model Number	7207598
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the device was bent.No back-up device was available.No patient injury reported.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7589248
• Report Number: 1219602-2018-00716
• Device Sequence Number: 2193853
• Product Code: NBH
• UDI-Device Identifier: 03596010427311
• UDI-Public: (01)03596010427311(10)50535246
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1