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

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

Patient Problem Necrosis (1971)

Event Type  malfunction  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2019-00424: case 1, 3025141-2019-00425: case 2.

Event Description

Article: internal fixation of proximal humeral fractures using the polarus intramedullary nail, kazakos, k., lyras, d.N., galanis, d., verettas, d., psillakis, i., chatzipappas, ch., xarchas, k.; arhc orthop trauma surg (2007) 127: 503-508.Case 3: patient experienced avascular necrosis of the head of the humerus following implantation of a polarus humeral nail.

• 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: 9244931
• MDR Text Key: 182572101
• Report Number: 3025141-2019-00426
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• 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: 10/01/2019
• 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