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

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Report 8 of 9.Between (b)(6) 2016 to (b)(6) 2022, 36 patients (37 wrists) underwent a total wrist arthrodesis surgery at a different uk hospital (table 10).The average age was 49.1 years ± 12.6 years (range 26-75 years).The majority of total wrist arthrodesis was in the right hand (n=22), with 14 left wrists and 1 wrist was not indicated for sidedness.No data for hand dominance were reported.Patients were followed up on average for 1.76 years ± 1.73 years (range 0.11-6.0 years).Two patients were lost to follow-up after the sutures were removed; one of these patients also had a concomitant carpal tunnel decompression (ctd) and the other had a proximal row carpectomy (prc).All patients used the acumed total wrist fusion plate system and used acumed instrumentation to place the implanted device.In total, 25 neutral plates (70-0362), 2 left plates (unknown if standard 70-0325 or small 70-0327), 7 right plates (unknown if standard 70-0326 or small 70-0328), and 3 unknown plates (1 was either left or right, 2 other plates were used in the right hand) were implanted.The majority of patients underwent total wrist arthrodesis without additional procedures.Eleven (11) patients underwent a concomitant procedure for a proximal row carpectomy (prc) (n=8), carpal tunnel decompression (ctd) (n=1), a prc with ctd (n=1), or an extensor indicis proprius (eip) to extensor digitorum communis (edc) tendon transfer (n=1).The complications included two patients with ulnocarpal abutment post-fusion, one patient with carpal tunnel syndrome, one patient ulna positive, one patient with dorsal hand pain, one patient with ongoing pain, and one patient with peri-prosthetic fracture.After union was achieved 15 patients had their plates removed (routine removal).These plate removals were not due to any of the listed complications.One (1) patient had a failed plate removal, and another patient (1) had a cold weld screw during removal.There are 9 related report numbers for this event 3025141-2023-00590 through 3025141-2023-00598.

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 information is unknown.Based on the information received, the root cause could not be determined.

• 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: 17971272
• MDR Text Key: 326125730
• Report Number: 3025141-2023-00597
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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: 09/22/2023
• 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