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

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

Patient Problem Joint Contracture (4528)

Event Type  Injury  

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 could not be determined.

Event Description

Report 1 of 2.In the article " free functional muscle transfer and one bone forearm for upper-extremity limb salvage after high-energy ballistic trauma" by defoor, m.T., et al, the authors discussed a case report of a 45 year old male patient who presented after sustaining a high-velocity gunshot to the left volar forearm during a mass casualty shooting.He sustained large cavitary soft tissue, muscle, and nerve defects to the volar forearm, with diffuse sensory loss to the hand and dysvascular limb with no dopplerable signal distal to the elbow.Injury films demonstrated comminuted proximal ulna and radius shaft fractures with 8 cm of bone loss.He was immediately taken to the operating room for exploration, revascularization, and temporary fracture stabilization.Intraoperatively, segmental transection of the radial and ulnar arteries was found just distal to the volar forearm compartment musculature had extensive muscle loss spanning the myotendinous junctions, most of which was debrided at the index operation.After revascularization, he underwent provisional internal fixation of the ulna with a bridge plate construct for bony stabilization and protection of the vascular repair and fasciotomies.After shared decision-making, the patient desired limb salvage with one bone forearm with the understanding that he would lose the ability to pronosupinate after being fixed in forearm pronation.The patient underwent serial debridements prior to definitive stabilization with a one bone forearm, requiring an 8 cm nonvascularized graft from the ipsilateral distal ulna.Owing to the prior radial artery revascularization from the brachial artery with rgsv and anticipation for large soft tissue flap coverage requiring anastomosis to the brachial artery, a nonvascularized bone graft was preferred over a vascularized graft because there was not enough real estate to the recipient for an additional vascularized graft.A 15- hole olecranon plate (acumed llc) was used for proximal fixation of the distal ulna segmental graft to the proximal ulna, and a 6-hole 3.5 mm straight forearm plate (acumed llc) was placed perpendicularly to span the proximal and distal ends of the segmental graft, with the forearm fixed in 50 of pronation.Eleven months after surgery (event date unknown), he underwent extensor tendon tenolysis and capsulotomy at the metacarpal phalangeal joints for contracture owing to imbalance of flexor and extensor tendons.Related report: 3025141-2023-00609.

• 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: 18026795
• MDR Text Key: 326791125
• Report Number: 3025141-2023-00608
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2023
• 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: 10/09/2023
• 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: 45 YR
• Patient Sex: Male