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

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

Patient Problem Muscle Weakness (1967)

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2019-00532: case 1, 3025141-2019-00533: case 2, 3025141-2019-00534: case 3, 3025141-2019-00535: case 4, 3025141-2019-00536: case 5, 3025141-2019-00537: case 6, 3025141-2019-00538: case 7, 3025141-2019-00539: case 8, 3025141-2019-00540: case 9, 3025141-2019-00541: case 10, 3025141-2019-00542: case 11.

Event Description

Article: operative treatment of 2-part surgical neck fractures of the humerus: intramedullary nail versus locking compression plate with technical consideration; lee, wonyong, md; park, jun-youn, md; chun, yong-min, md phd; j orthop trauma, volume 31, number 9, september 2017; 270-274.Case 12: patient experienced supraspinatus weakness in forward flexion following implantation of a polarus nail; no rotator cuff tear.

• 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: 9291021
• MDR Text Key: 183131751
• Report Number: 3025141-2019-00543
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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: 10/25/2019
• 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