MAUDE Adverse Event Report: ARTHREX, INC. GRSPR,BLNT 3.4 MMSTR W/NR HNDL; ACCESSORIES, ARTHROSCOPIC

Model Number	GRSPR,BLNT 3.4 MMSTR W/NR HNDL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the ar-12500nr grasper is broken.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-12500nr, batch 40956 grasper was received for investigation.Functional testing identified that when the 111-301p finger was manipulated, the 113-305 grasper jaw would not actuate in response.The observed condition is typically caused by applying excessive force while grasping tissue, leading to breakage of the shear pin.

• Brand Name: GRSPR,BLNT 3.4 MMSTR W/NR HNDL
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11797794
• Report Number: 1220246-2021-03017
• Device Sequence Number: 1009802
• Product Code: NBH
• UDI-Device Identifier: 00888867006218
• UDI-Public: 00888867006218
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: GRSPR,BLNT 3.4 MMSTR W/NR HNDL
• Device Catalogue Number: AR-12500NR
• Device Lot Number: 40956
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1