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	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip is broken off.18-nov-2021 update: further information were provided that the reported event occurred some time ago during a surgery.The customer does not remember when and how the tip of the reported device broke off.The surgeon reported that there was no harm for patient, operator or third party.No further information are available.
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 tip is broken off.18-nov-2021 update: further information were provided that the reported event occurred some time ago during a surgery.The customer does not remember when and how the tip of the reported device broke off.The surgeon reported that there was no harm for patient, operator or third party.No further information are available.
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.One unpackaged ar-11900sr, batch 44175 was received for investigation.Visual inspection identified that the lower jaw was missing from the returned ar-11900sr, although the remaining upper jaw component was still able to be actuated as intended.Additionally, the shaft was observed to be bent.The cause remains undetermined, although a probable cause can be attributed to user applied mechanical forces during use, such as through prying/leveraging the device.

• 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: 12953290
• Report Number: 1220246-2021-04047
• Device Sequence Number: 11859425
• 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): 12/14/2021

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: GRASPER, MINI, 2.75 MM W/SR HANDLE
• Device Catalogue Number: AR-11900SR
• Device Lot Number: 44175
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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