MAUDE Adverse Event Report: ACUMED, LLC ARC WRIST TOWER TRAY 1 OF 2; APPARATUS, TRACTION, NON-POWERED

Model Number 10100001

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.

Event Description

During the pre-op phase of a wrist arthoscopy surgery, an "open box failure" was found and resulted in a 20 minute delay of the procedure.The procedure was completed and no alternate device was used.It was reported that there was no patient or user impact.Attempts to obtain further information regarding the "open box failure" have been made to no avail.

Manufacturer Narrative

The returned arc wrist tower assembly (part number 10100001) was examined visually under magnification.Batch number 523151 was confirmed on all subcomponents of the assembly.All subcomponents appeared clean without any defects or blemishes.One tray appeared to have some scratches over words in the instruction panel.Functional testing was performed.The arc wrist tower tray 1 and 2 were opened with side latches without any issues.All parts were placed in their respective locations in the tray and were able to be removed easily.The tower was able to be assembled fully.The two bolts on the bottom arm plate were fully tightened in their closed position.They had to be loosened counterclockwise to be able to allow the top upper arm plate to be placed in position and secured.If these two bolts are not loosened, the upper arm plate cannot be secured in place.All other parts were able to be assembled without any prior loosening of bolts or screws.No definitive conclusion on the cause of the reported event could be made.

• Brand Name: ARC WRIST TOWER TRAY 1 OF 2
• 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: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14246038
• MDR Text Key: 294666225
• Report Number: 3025141-2022-00118
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10100001
• Device Catalogue Number: 10100001
• Device Lot Number: 523151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1