MAUDE Adverse Event Report: CONMED UTICA ASSISTARM SURGICAL POSITIONER; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number	AA-PSN100
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device, aa-psn100, assistarm surgical positioner, was being pre-op tested for a shoulder orif procedure on 1nov23 when it was reported, ¿positioner was stuck when trying to use pedal to adjust.User adjusted manually and positioner moved and caught users finger.Tufts fracture on left hand ring finger of user.¿.There was no report of medical intervention or hospitalization for the user.Further assessment questions have not been answered to date.The procedure was completed as planned with no delay being reported.This report is being raised due to the reported injury of user left hand ring finger being fractured.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Additional Manufacturer Narrative
Evaluation of the device could not confirm the report event; however additional issues were found that include: bearing ¿ corroded/damaged, hose ¿ damaged, rubber feet damaged, upgrade and screw ¿ loose/damaged/missing.A device history record (dhr) review was not conducted as the device has been in the field greater than 12 months.The service history was reviewed and found similar repairs to this complaint.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: inspect the assistarm¿ products and the surgical table before each use and use them only if they are in good condition.Injuries that may occur due to a pinch point between the various component parts of the assistarm¿ surgical positioner and its accessories during installation of use.Ensure adequate patient and user clearance from moving part of assistarm¿ surgical positioner and its accessories.The assistarm¿ products can be damaged if liquid or solid contaminants get inside the mechanisms.Prevent the ingress of contaminants, detergents and disinfectants in the mechanisms of the assistarm¿ products.Make sure to cover well the spherical joints of the assistarm¿ surgical positioner with a waterproof material when they are likely to be exposed to such contaminants.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, aa-psn100, assistarm surgical positioner, was being pre-op tested for a shoulder orif procedure on (b)(6) 2023 when it was reported, ¿positioner was stuck when trying to use pedal to adjust.User adjusted manually and positioner moved and caught users finger.Tufts fracture on left hand ring finger of user.¿.There was no report of medical intervention or hospitalization for the user.Further assessment questions have not been answered to date.The procedure was completed as planned with no delay being reported.This report is being raised due to the reported injury of user left hand ring finger being fractured.

• Brand Name: ASSISTARM SURGICAL POSITIONER
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18236051
• Report Number: 1320894-2023-00259
• Device Sequence Number: 20620928
• Product Code: FWZ
• UDI-Device Identifier: 10845854043578
• UDI-Public: (01)10845854043578
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AA-PSN100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic