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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00126: driver, 3025141-2020-00145: plate.

Event Description

While implanting aculoc 2 vdr plate, the driver tip broke off in the head of one of the screws.The driver tip could not be removed and was left implanted.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, or
• MDR Report Key: 10121428
• MDR Text Key: 194318181
• Report Number: 3025141-2020-00127
• Device Sequence Number: 1
• Product Code: HWC
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• 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: 05/21/2020
• 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 Age: 64 YR
• Patient Weight: 68