MAUDE Adverse Event Report: ACUMED LLC POST-LAT DISTAL HUMERUS PLATE 11 HOLE RT; PLATE, FIXATION, BONE

Model Number 70-0379

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

While implanting a posterolateral humeral plate, a locking 3.5 hexalobe screw was begin inserted.The head of the screw broke off but the remaining portion of the screw was intact and holding the plate in place.Later in the case, it became apparent that the plate's position need to be shifted, but the broken screw did not allow this so the plate was bent and cut to remove it and was replaced by another plate.There was a 15 minute delay in surgery as a result.

Manufacturer Narrative

Additional mdr associated with this event: 3025141-2021-00138: screw.

• Brand Name: POST-LAT DISTAL HUMERUS PLATE 11 HOLE RT
• Type of Device: PLATE, 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 ; 5032071387
• MDR Report Key: 12759679
• MDR Text Key: 282817857
• Report Number: 3025141-2021-00139
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0379
• Device Catalogue Number: 70-0379
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• 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 Sex: Male