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

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2019-00442: case 1, 3025141-2019-00443: case 2, 3025141-2019-00444: case 3, 3025141-2019-00445: case 4, 3025141-2019-00446: case 5, 3025141-2019-00448: case 7, 3025141-2019-00449: case 8.

Event Description

Article: surgical treatment of displaced proximal humerus fractures with a short intramedullary nail, nolan, betsy m.Md; kippe, matthew a., md; wiater, michael, md; nowinski, gregory p., md; j shoulder elbow surg (2011) 20, 1241-1247.Case 6: patient underwent revision surgery to remove polarus nail hardware due to loss of fixation or prominent hardware.

• 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: 9251490
• MDR Text Key: 164235746
• Report Number: 3025141-2019-00447
• 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?: Yes
• Is this a Product Problem Report?: No
• 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
• Patient Outcome(s): Required Intervention