MAUDE Adverse Event Report: ACUMED LLC ARC WRIST TOWER UPPER ARC; APPARATUS, TRACTION, NON-POWERED

Model Number 10100015

Device Problem Degraded (1153)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

Returned product examined visually under magnification.All threaded features were inspected and found to be in good condition.Welds connecting the arm sleeves to the locking joint have cracked.Additional mdrs associated with this event: 3025141-2019-00097: rosette knob 1, 3025141-2019-00098: rosette knob 2, 3025141-2019-00099: tower wrist joint.

Event Description

During surgery on the patient's arm, it was supported by the arc wrist tower.During the surgery, the surgeon found tiny metal flakes in the wound.The flakes were coming from the arc wrist tower.All of the metal flakes were not successfully removed from the wound, as some were sticking to the synovium even when washed thoroughly.There was a delay in surgery as a result of this situation.

• Brand Name: ARC WRIST TOWER UPPER ARC
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• 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: 8301473
• MDR Text Key: 134902175
• Report Number: 3025141-2019-00100
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10100015
• Device Catalogue Number: 10100015
• Device Lot Number: 331081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 113