MAUDE Adverse Event Report: ACUMED, LLC; PLATE, FIXATION, BONE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Inflammation/ Irritation (4545); Implant Pain (4561)

Event Type  Injury  

Event Description

In the article " ulna autograft for wrist arthrodesis: a novel approach in failed wrist arthoplasty" by sargazi, m., et al, the authors described a new technique for wrist arthrodesis, using an ulna strut autograft, as a salvage procedure in those with failed arthroplasty for severe rheumatoid arthritis.The authors discussed two case studies.A 58-year old, right hand dominant factory worker with a background of previous left sided distal radial fracture and advanced rheumatoid arthritis was referred to their local hand unit following failure of medical management of chronic wrist pain and progressive joint deformity.Clinically the patient was noted to have a subluxed left wrist with radiological features of advanced ra and malunion of the distal radial fracture.Furthermore, there was clinical evidence flexor digitorum profundus (fdp) rupture in the left middle and index fingers, in addition to extensive tenosynovitis of the middle finger and epl rupture involving the right hand.Initial management involved addressing symptoms within her dominant hand with the patient undergoing dorsal wrist synovectomy and extensor indicis proprius (eip) tendon transfer to address the ruptured extensor pollicis longus (epl) tendon.Whilst she recovered well from the above procedures, symptoms within the left hand continued to deteriorate with the patient developing profound neuropathic pain in the left side.Clinically, the patient was now exhibiting evidence of muscle wasting within the left forearm alongside inability to flex all digits with ongoing deformity of the wrist.Therefore a left total wrist replacement was undertaken to address these issues.Post-operatively, the patient exhibited a drastic improvement in both symptoms and function with ability to dorsiflex and plantarflex to 45 degrees and 20 degrees respectively, in addition to maintaining full supination and pronation.Unfortunately, the patient went on to develop atraumatic dislocation of the wrist replacement 8 years following the arthroplasty.Therefore, the patient underwent removal of the wrist replacement followed by arthrodesis of the wrist joint with an ulna strut graft.This ulna strut graft involved a standard fusion plate (manufactured by acumed llc) being fixed to the dorsum of the metacarpal, ulna graft and radial shaft using locking standard screws.A small volume of bone may also be used to provide additional packing at the proximal and distal ends of the strut graft.After arthodesis of the patient's wrist joint with an ulna strut graft, the patient progressed well post-operatively, with imaging at 2 months post-operatively illustrating evidence of graft take and bone healing.Approximately, 12 months following the arthrodesis (event date unknown), the patient's main complaint was prominence of the distal portion of the fusion plate and subsequent skin irritation.The patient subsequently underwent removal of the fusion plate at 13 month post-arthrodesis with intra-operative imaging and direct inspection of the fusion site showing evidence of complete bone healing and graft take.It was reported the patient continues to remain under follow-up.This was an off-label use of the acumed wrist spanning plate to perform a total wrist arthrodesis.

Manufacturer Narrative

The device was not received for evaluation.Manufacturing and inspection records could not be reviewed as device information is unknown.Based on the information received, it was reported the acumed wrist spanning plate was used to perform a total wrist arthrodesis which is an off-label use of this device.

• Type of Device: PLATE, FIXATION, BONE
• 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: 18030818
• MDR Text Key: 326864680
• Report Number: 3025141-2023-00610
• Device Sequence Number: 1
• Product Code: HRS
• 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,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female