MAUDE Adverse Event Report: ACUMED LLC 3.0MM X 45MM LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 30-0295

Device Problems Fitting Problem (2183); Torn Material (3024)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2016-00215: plate.3025141-2016-00216: screw 1.3025141-2016-00217: screw 2.3025141-2016-00218: screw 3.3025141-2016-00219: screw 4.3025141-2016-00220: screw 5.3025141-2016-00221: screw 6.3025141-2016-00222: screw 7.3025141-2016-00223: screw 8.3025141-2016-00224: screw 9.

Event Description

While implanting an olecranon plate, it was determined that there was not an ideal size of plate to use.A 5 hole olecranon plate was used.The result was that the proximal fragment pulled out and tore through the screws postop.The plate was explanted and replaced with a different size plate.

• Brand Name: 3.0MM X 45MM LOCKING HEXALOBE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 5036279957
• MDR Report Key: 6086392
• MDR Text Key: 59453143
• Report Number: 3025141-2016-00225
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 30-0295
• Device Catalogue Number: 30-0295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2016
• 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: 83 YR