MAUDE Adverse Event Report: ACUMED LLC; SCREW, FIXATION, BONE

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2016-00238: plate.

Event Description

While implanting an olecranon plate, it was determined that there was not an ideal size of plate to use.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.

• 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: 6086495
• MDR Text Key: 59422260
• Report Number: 3025141-2016-00239
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/08/2016
• 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