MAUDE Adverse Event Report: ACUMED LLC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

Device Problem Positioning Problem (3009)

Patient Problem Irritation (1941)

Event Type  malfunction  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2019-00414: case 1, 3025141-2019-00415: case 2, 3025141-2019-00416: case 3.

Event Description

Article: treatment of proximal humeral fractures with polarus nail fixation nail, agel, julie, ma; jones, clifford b, md; sanzone, anthony g., md; camuso, matthew, md; henley, m.Bradford, md; journal of shoulder and elbow surgery, 2004, volume 13, number 2, 191-195.Case 4: patient had a proximal screw that penetrated the articular surface, following implantation of a poalrus nail.The nail was locked proximally above the osseous surface, which potentially created the subacromial irritation.

• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9241795
• MDR Text Key: 182571300
• Report Number: 3025141-2019-00417
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• 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