MAUDE Adverse Event Report: ACUMED, LLC TOWER PIVOT JOINT; APPARATUS, TRACTION, NON-POWERED

Model Number 10100001

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records could not be reviewed as device batch/lot number is unknown.Based on the information received, the root cause could not be determined.

Event Description

It was reported the screw responsible for stabilizing the wrist joint of the arc wrist tower was missing, and "an obdurator was placed in stay of the screw to substitute the system".Further information obtained revealed the incident most likely occurred before the surgery in the sterile processing department of the facility.It was reported this issue caused issues during the surgery because the device did not function as intended and therefore prolonged the procedure.It is unknown how long the procedure was delayed.No adverse patient consequences were reported.

Manufacturer Narrative

The device was received for evaluation on 23 august 2023, and based on the device received, the product information (model number, batch/lot number) was updated.Manufacturing and inspection records were reviewed, and no anomalies were noted.As received, the cam lever was detached from the wrist joint subassembly, and the 97345a495 (shoulder screw) was missing.The cam lever was able to be reattached to the wrist joint subassembly with a new 97345a495 (shoulder screw).Subsequently, the device was inspected and met specification.Corrected data: d4: model number and catalog number updated to 10100001.D4: lot number updated to: 459637 as this information was previously unknown.D4: udi updated to: (b)(4).The following coding in h6 were updated: -type of investigation code (annex b) updated to 10- testing of actual/suspect device and 3331- analysis of production records.-investigation findings code (annex c) updated to 180- mechanical problem identified.

• Brand Name: TOWER PIVOT JOINT
• 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
• MDR Report Key: 16865887
• MDR Text Key: 314531608
• Report Number: 3025141-2023-00299
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 459637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/23/2023
• 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: Unknown
• Patient Sequence Number: 1