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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neuropathy (1983)

Event Type  Injury  

Event Description

In a preprint (not peer reviewed) article " effect of intraoperative hand-grip position on surgical outcome of thumb carpometacarpal arthrodesis" by alvin, k.A., et al, the authors performed a retrospective review aimed to evaluate the efficacy of our intraoperative hand-grip positioning method for arthrodesis of thumb carpometacarpal joint (cmcj) osteoarthritis (oa).20 patients with cmcj oa underwent arthrodesis using their intraoperative hand-grip positioning method and t-hook plates and screws (acumed llc, usa).Patients were evaluated preoperatively and at 1, 3, 6 and 12 months postoperatively.Radiologic assessment including fusion evaluation, evaluation of radial and palmar abduction angles was done on hand x-rays.The authors also performed a literature review to understand the current trends and techniques of arthrodesis for comparison.20 patients with a minimum follow-up duration of 12 months were included in this study.100% fusion rate was achieved with only 1 case of complication involving radial sensory nerve neuropathy which was resolved after removal of implant and neurolysis.

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, the root cause of the reported event is unknown.

• 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: 18095468
• MDR Text Key: 327669328
• Report Number: 3025141-2023-00618
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: 10/23/2023
• 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