MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 1.55MM X 10MM FLUTED TWIST DRL; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number S-1510TD

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from france that during an unspecified surgery, it was observed that the cutter device had a cluster of metallic small particles.According to the report, the device had been in contact with bodily tissue prior; therefore, the particles remained intact on the reconstruction component.It was further reported that there was no other malfunction other than the presence of small particles.It was not reported if there was a delay to the surgical procedure or whether a spare device was available for use.It was not reported if the procedure was completed successfully.There was no patient harm/injury observed; however, the patient's condition post-surgery was unknown.It was not reported if there was a medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

During subsequent follow-up with the reporter, it was clarified that the metallic particles were coming from the drill but and not from the re-construction component.It was further reported that there was no visual damage to the device prior to use.It was also reported that the reconstruction component was reported to be the cement used after craniotomy (ablation of the bone of the skull).The bone is replaced by bone cement.The ¿reconstruction component¿, cement, was not an implantable device from synthes.The little metallic particles remained stuck in the ¿reconstruction component¿.The reconstruction component, cement, was left implanted inside the patient, with some metallic particles stuck on it, and could not be removed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).The device manufacture date was documented as unknown in the initial report.It has been updated to march 31, 2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Correction: the date returned to manufacturer was documented as mar 7, 2017 on the previous report.It has been updated as apr 26, 2017.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Observed that the device passed all manufacturing specifications.A visual assessment was performed on the device which found that melted cement particles were present on the fluted area of the drill.It was determined that this device was being used by the customer to drill bone cement.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.55MM X 10MM FLUTED TWIST DRL
• Type of Device: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 6396593
• MDR Text Key: 69637056
• Report Number: 1045834-2017-10612
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-1510TD
• Device Lot Number: J133104731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention