MAUDE Adverse Event Report: IHB OPERATIONS B.V. SKYTRON; 3AFC-M SPRING ARM

Model Number 3AFC-M

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2018

Event Type  malfunction  

Event Description

Model #: 3afc-m (sn:(b)(4)) from boom f fell during a case at (b)(6) medical center.Skytron distributor, (b)(4) confirmed the serial number from the hub of the boom that the 3afc-m fell from.Serial number (b)(4) is the serial attached to a light weight hub that was used for boom f on shop order (b)(4) and on customer order (b)(4) for (b)(6) medical center.During our investigation we have photo documentation that the 3afc-m (sn: (b)(4)) was not installed at skytron and was installed in the field during installation.We were not able to locate the installation records on service bridge at this time from the (b)(4).From the photos and the information that we were provided from the (b)(4), it was determined that the brass brake key ((b)(4)) was not installed and is a primary support for holding the 3t2 arm and the 3afc arm together.The ball stop boss ((b)(4)) was installed but that alone cannot support the 3afc-m to the 3t2 sufficiently.The only force that was holding the 3afc-m to the 3t2 was the cantilever weight.It was later determined that the 3afc-m has cosmetic damage and could be attached to boom f after a new hardware set containing new covers and mounting equipment replaced any damaged covers during the fall.The applicable replacement parts were ordered by the (b)(4).Po: (b)(4) was sent in from the (b)(4) for 2x replacement hardware kits.One being the hardware kit for a 3afc ((b)(4)) and the other being the hardware kit for 3t2 ((b)(4)).Both of these kits were given to (b)(4) while he was skytron.He will be bringing these kits back with him on his way back to (b)(4) on 03/28/2018 to reinstall 3afc-m (sn: (b)(4)) to boom f at (b)(6) medical center.Skytron complaint number (b)(4).There were no reported injuries.

• Brand Name: SKYTRON
• Type of Device: 3AFC-M SPRING ARM
• Manufacturer (Section D): IHB OPERATIONS B.V.; po box 79; 8000 ab zwolle; zwolle, ; NL
• MDR Report Key: 7402570
• MDR Text Key: 105181451
• Report Number: 1825014-2018-00004
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3AFC-M
• Device Catalogue Number: 3AFC-M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2018
• Distributor Facility Aware Date: 03/28/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other