MAUDE Adverse Event Report: AESCULAP AG TWIST DRILL 2MM DIA NSTRUMENTS FOR NEUROSURGERY

Model Number FF068R

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: the drill ff068r is available for investigation decontaminated according to the internal standards. The broken off working end is missing. Additionally we received a broken gc004r. A request has been placed to clarify to which incident this drill must be attributed. Vigilance investigator carried out the pictorial documentation visually and microscopically. No pores, inclusions or foreign bodies could be found on the point of rupture. Small brownish spots can be recognized on the fracture pattern, presumably caused by the processing after the breakage. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. The breakage of the drill was most likely caused by an overload situation, presumable caused by tumbling during application. For example during application with a hudson brace hand drill.

Event Description

It was reported that there was an issue with a twist drill 2mm dia. According to the complaint description: "when a brain pressure probe was applied, the drill broke off and became partially stuck in the skull bone. The broken part had to be removed from the bone. The patient had to be transported to the operating room and a small craniectomy had to be performed. " the adverse event/malfunction is filed under (b)(4.

• Brand Name: TWIST DRILL 2MM DIA
• Type of Device: NSTRUMENTS FOR NEUROSURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8920873
• MDR Text Key: 155209183
• Report Number: 9610612-2019-00576
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/22/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: FF068R
• Device Catalogue Number: FF068R
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 08/22/2019 Patient Sequence Number: 1