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

Model Number	7207598
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during anchor arthroscopy the micrograsper straight won¿t close, is broken.The device was outside of the patient at the moment of the failure.There was no delay and it is unknown how the procedure was completed.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: one 7207598 micrograsper straight has returned for evaluation.This is a two year old reusable device.The complaint stated: ¿during anchor arthroscopy the micrograsper straight won¿t close, is broken¿.Visual assessment confirms complaint.The jaws would not close.An exact root cause cannot be determined with confidence.However, factors that could have contributed to the reported event include: inadequate cleaning of device or excessive force.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaint batch records was preformed, no other complaints of this failure was found.

• Brand Name: MICROGRASPER STRAIGHT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10474562
• Report Number: 1219602-2020-01335
• Device Sequence Number: 19535369
• Product Code: NBH
• UDI-Device Identifier: 03596010427311
• UDI-Public: 03596010427311
• 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): 10/07/2020

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: 50758846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1