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

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

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2019-00544: case 1; 3025141-2019-00545: case 2; 3025141-2019-00546: case 3; 3025141-2019-00547: case 4; 3025141-2019-00548: case 5; 3025141-2019-00549: case 6; 3025141-2019-00550: case 7; 3025141-2019-00551: case 8; 3025141-2019-00552: case 9.

Event Description

Article: management of displaced surgical neck fractures of the humerus: health related quality of life, functional and radiographic results; urda, antonio; gonzalez, ana; colino, alvaro; lopiz, yaiza; garcia-fernandez, carlos; marco, fernando; injury, int.J.Care injured (2012) 43 (s2), s12-s19.Case 10: patient developed a nonunion following implantation of a polarus nail and was treated with reverse shoulder arthroplasty.

• 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 ; 8886279957
• MDR Report Key: 9296072
• MDR Text Key: 165597707
• Report Number: 3025141-2019-00553
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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: 10/30/2019
• 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
• Patient Age: 76 YR