MAUDE Adverse Event Report: ACUMED, LLC TOWER WRIST JOINT LOCKING ROSETTE KNOB; APPARATUS, TRACTION, NON-POWERED

Model Number 10150143

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing records review was performed for the batch number for the entire assembly of the traction tower.No anomalies were noted.The part number 10150143 "tower wrist joint locking rosette knob" and part number 10100014 "tower wrist joint" were returned for evaluation.The knob and joint were returned with the knob stuck in the hole closest to the udi mark.It was attempted to remove the knob by hand; however, the attempt was unsuccessful due to high resistance.Hand tools were used to successfully remove the knob.Functional testing was performed which involved testing engagements between the knob and joint using returned parts and known-functional equivalent parts from the engineering lab arc wrist tower tray to gauge differences when inserting the knob into the udi-side hole of the joint.The returned knob was not used in the test due to the knob being heavily bent; it was unable to engage with other parts.The following sub-tests were performed with the noted combination of parts: [lab joint, lab knob] this was effectively a control test, as both parts were known-functional.Results were that the knob successfully threaded into both holes of the joint with little to no resistance impeding insertion.[returned joint, lab knob] results were that the knob could only insert into the udi-side hole approximately 0.21 inches before significant resistance prevented further insertion by hand.The returned parts were examined without and with magnified photography.Observed phenomena included: [joint hole damage] the udi-side hole in which the knob was originally stuck exhibited thread wear.Threading damage was present on all threads of this hole, with damage worsening further into the hole with light corrosion at the peak/crest of the final turn of thread deepest in the hole.[knob shaft damage] the 7 turns of thread closest to the tip exhibit thread wear; the 2 turns of thread nearest the tip were nearly fully sheared.The threaded shaft of the knob was bent, with the bend centered approximately 0.29 inches from the tip; the knob shaft was bent at approximately an 11 degree angle.The event description denoted that the knob "was screwed into 10100014.At an angle".Off-axis (angled) insertion, in combination with threading wear on both components, may increase chances of cross-threading leading to an impaired engagement.However, based on the information received, the root cause could not be determined.

Event Description

On 29 august 2022, it was initially reported by a company employee in the returns department that the 10150143 [tower wrist joint locking rosette knob] was screwed into 10100014 [tower wrist joint] at an angle and was cross threaded and stuck.After continued follow up, on 19 september 2022, information received from the surgical tech at the facility indicated, during the procedure, the upper arc rosette knob was cross threaded and was stuck.This resulted in the physician assistant having to hold the patient's arm so it would not move while the surgeon performed the procedure.This resulted in a 10-15 minute delay in procedure.There were no adverse patient consequences.This report is related to report number 3025141-2022-00318 for the other device involved in this event.

• Brand Name: TOWER WRIST JOINT LOCKING ROSETTE KNOB
• 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: 15471186
• MDR Text Key: 306201654
• Report Number: 3025141-2022-00317
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10150143
• Device Catalogue Number: 10150143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2019
• 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 Sex: Female