MAUDE Adverse Event Report: ACUMED LLC 3.0MM X 230MM ULNA ROD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES: ROD

Model Number UL-3023-S

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

The returned 3.0mm ulna nail, im rod targeting base, and im rod locking bolt were visually and functionally examined.The three products were returned together in a single assembly.The locking bolt was able to disengage from the ulna nail when un-screwed from the assembly but couldn't not disengage from the targeting base.The locking boot can spin/turn within the targeting base but will not retract, likely due to thread stripping of the locking bolt but this cannot be seen without destroying the targeting base.Scratches were present on both the targeting base and locking bolt, likely from the multiple removal attempts indicated.The interfacing surfaces of the ulna nail and targeting base were smooth upon examination.Additional mdrs associated with this event.3025141-2021-00004: targeting base.3025141-2021-00005: locking bolt.

Event Description

During removal of an ulna rod and screws (removal for unknown reasons), the screws came out with no issues but the surgeon had difficulties removing the rod.Using two of the components of the targeting guide to help with removal, they were finally able to remove the nail after a 45 minute delay in surgery and use of a competitor's nail removal process.Once removed, the targeting guide components were cold welded to the nail and could not be separated.They are no longer usable.

• Brand Name: 3.0MM X 230MM ULNA ROD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES: ROD
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 11219028
• MDR Text Key: 230091136
• Report Number: 3025141-2021-00003
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Model Number: UL-3023-S
• Device Catalogue Number: UL-3023-S
• Device Lot Number: 365172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR