MAUDE Adverse Event Report: ACUMEDLLC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2019-00450: case 1, 3025141-2019-00451: case 2, 3025141-2019-00452: case 3, 3025141-2019-00453: case 4, 3025141-2019-00454: case 5, 3025141-2019-00455: case 6, 3025141-2019-00456: case 7, 3025141-2019-00457: case 8, 3025141-2019-00458: case 9, 3025141-2019-00459: case 10, 3025141-2019-00461: case 12, 3025141-2019-00462: case 13, 3025141-2019-00463: case 14, 3025141-2019-00464: case 15, 3025141-2019-00465: case 16, 3025141-2019-00466: case 17, 3025141-2019-00467: case 18, 3025141-2019-00468: case 19, 3025141-2019-00469: case 20, 3025141-2019-00470: case 21, 3025141-2019-00471: case 22, 3025141-2019-00472: case 23.

Event Description

Article: proximal humerus nailing: a randomized clinical trial between curvilinear and straight nails, lopiz, yaiza, phd, md; garcia-fernandez, carlos, md; marco, fernando, phd, md; j shoulder elbow surg (214) 23, 369-376.Case 11: patient experienced loosening of one or more screws used with polarus nail post operatively.

• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
• Manufacturer (Section D): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 9251552
• MDR Text Key: 182942732
• Report Number: 3025141-2019-00460
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/29/2019
• 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