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

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2019-00428: case 2, 3025141-2019-00429: case 3, 3025141-2019-00430: case 4, 3025141-2019-00431: case 5, 3025141-2019-00432: case 6, 3025141-2019-00433: case 7, 3025141-2019-00434: case 8, 3025141-2019-00435: case 9, 3025141-2019-00436: case 10, 3025141-2019-00437: case 11, 3025141-2019-00438: case 12.

Event Description

Article: internal fixation of proximal humeral fractures with a polarus humeral nail, koike, yoichi; komatsuda, tatsuro; sato, katsumi; j orthopaed traumatol (2008) 9: 135-139.Case 1: patient experienced superficial wound infection following implantation of a polarus nail that was treated with local wound care and antibiotics.

• 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: 9244938
• MDR Text Key: 164072497
• Report Number: 3025141-2019-00427
• 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?: Yes
• Is this a Product Problem Report?: No
• 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
• Patient Outcome(s): Required Intervention