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

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2021-00096 follow up 1: screw 1, 3025141-2021-00112: screw 2, 3025141-2021-00113: screw 3, 3025141-2021-00114: screw 4, 3025141-2021-00115: screw 5.

Event Description

Screws were used to secure a bone plate to a fractured bone.At some point post op, multiple screws broke.During the explant surgery, more screw heads broke off, the screws stripped and the removal tools did not work.There were a total of 5 broken screws which were smoothed down and left implanted in the bone.There was a 20 minute delay in surgery to deal with the situation.

• 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: 12590885
• MDR Text Key: 276346043
• Report Number: 3025141-2021-00116
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• 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 Outcome(s): Required Intervention