MAUDE Adverse Event Report: ARTHREX, INC. GRASPER, MINI, 2.75 MM W/SR HANDLE; ACCESSORIES, ARTHROSCOPIC

Model Number	GRASPER, MINI, 2.75 MM W/SR HANDLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the upper part of the grasp broke off.There was no harm for patient, operator or third party reported.No further information received.(b)(6) 2022 update dw.Further information were provided that the part broke off during a surgery.
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.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the upper moving jaw was broken off.The cause of this remains undetermined, however a probable cause can be attributed to prying/leveraging forces.

• Brand Name: GRASPER, MINI, 2.75 MM W/SR HANDLE
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14829328
• Report Number: 1220246-2022-05150
• Device Sequence Number: 4744010
• Product Code: NBH
• UDI-Device Identifier: 00888867003828
• UDI-Public: 00888867003828
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: GRASPER, MINI, 2.75 MM W/SR HANDLE
• Device Catalogue Number: AR-11900SR
• Device Lot Number: 32546
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown