MAUDE Adverse Event Report: ARTHREX, INC. ROTATOR CUFF GRASPER W/SR HANDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	ROTATOR CUFF GRASPER W/SR HANDLE
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2024
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
On 05/13/2024 it was reported by a distributor via (b)(4) that an ar-13960sr rotator cuff grasper w/sr handle was rusted and would not cut.This occurred during use.No additional information was provided.
Additional Manufacturer Narrative
The complaint allegation of the device being rusted is confirmed.One unpackaged ar-13960sr rotator cuff grasper w/sr handle lot number: 74831 was received for investigation.Visual evaluation of the device noted wear and tear with discoloration observed throughout the device.The most likely cause for the reported failure of rest can be attributed to environmental due to the cleaning process performed.Dfu-0255-eo warns against usage of low acid or alkaline solutions as they will corrode metal parts and anodized aluminum and compromise plastics.If non-neutral ph cleaning chemistries need to be used, neutralization steps should be taken so as not to negatively impact the fit, finish, or function of the device.The second allegation of the device not cutting is not an intended function of this device and cannot be confirmed.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was provided on 05/16/2024, where it was stated that this event occurred during a shoulder surgery where the case was completed using another clamp.

• Brand Name: ROTATOR CUFF GRASPER W/SR HANDLE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19508710
• Report Number: 1220246-2024-05520
• Device Sequence Number: 7423725
• Product Code: NBH
• UDI-Device Identifier: 00888867015746
• UDI-Public: 00888867015746
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

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: ROTATOR CUFF GRASPER W/SR HANDLE
• Device Catalogue Number: AR-13960SR
• Device Lot Number: 74831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 05/16/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/19/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown