MAUDE Adverse Event Report: ACUMED LLC 3.5 X 26MM NL LOW PROFILE HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 3025-35026

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Material Integrity Problem (2978)

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

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00109: nail.

Event Description

While implanting a 3.5mm distal screw in a long rod, the screw would not fully seat due to the dense bone and non-aggressive cutting flutes on the screw.While trying to back the screw out, the screw stripped and broke.Caused a 45 minute delay in surgery.

• Brand Name: 3.5 X 26MM NL LOW PROFILE HEXALOBE SCREW
• Type of Device: SCREW, FIXATION, BONE
• 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: 10031122
• MDR Text Key: 190383153
• Report Number: 3025141-2020-00108
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3025-35026
• Device Catalogue Number: 3025-35026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• 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