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

Device Problems Break (1069); Failure to Align (2522)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2021-00076: guide 1, 3025141-2021-00077: guide 2.

Event Description

The primary guide broke during implantation of a rib plate.The guides were installed in compress mode per technique but when the resident drilled a couple of the holes he apparently got off axis.When the screws were then implanted, they did not line up with the slots in the posterior clip of the plate and instead created extra tension against the hook on the primary guide and the guide snapped.This happened with two guides during this surgery.There was a 15 minute delay in surgery time to locate the broken pieces in the patient.

• 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 ; 8886279957
• MDR Report Key: 12268254
• MDR Text Key: 266846391
• Report Number: 3025141-2021-00078
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• 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