MAUDE Adverse Event Report: ACRA CUT, INC. ACRA-CUT; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number 210-221

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2022

Event Type  Injury  

Event Description

Disposable cranial perforator broke while in use.Portion that broke was the connection inside the perforator attachment of stryker drill set removed from field and replaced.Both pieces retrieved.Fda safety report id # (b)(4).

• Brand Name: ACRA-CUT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): ACRA CUT, INC.; acton ME
• MDR Report Key: 13798170
• MDR Text Key: 287423538
• Report Number: MW5108210
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210-221
• Device Lot Number: 10134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White