MAUDE Adverse Event Report: AESCULAP AG HI-LINE CRANIOTOME CUTTER II; HIGHSPEED POWER SYSTEMS

Model Number GD805R

Device Problem Crack (1135)

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

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with hi-line craniotome cutter.According to the complaint description it was reported that the tool cracked during surgery.After the replacement of a new power system tool, no further problems and surgery was completed as planned.Sample or picture is not available.There was no patient harm.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

General information: we received a complaint about a gd805r - hi-line craniotome cutter ii regarding an intraoperative issue.We did not receive the complained product for investigation.Consequences for the patient: according to the provided information, there were no negative consequences for the patient.Investigation: due to a lack of components, a failure description is not possible.Batch history review: the device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot number (52459504).Conclusion and root cause: the failure is most probably usage related.Rationale: on the basis of the current information and without the product, a clear conclusion can not be drawn.After a dhr, a manufacturing related error can be excluded.Furthermore there is no indication for a material failure.It is possible that an overload situation in combination with wear an tear led to the breakage of the cutter.According to the ifu, the product has to be checked before each usage.Blunt tools shouldn't be used.Furthermore, based on the statistical analysis, there is no indication for a systematic failure.Corrective action: a capa is not necessary according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action).

• Brand Name: HI-LINE CRANIOTOME CUTTER II
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9992018
• MDR Text Key: 188727194
• Report Number: 9610612-2020-00139
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: GD805R
• Device Catalogue Number: GD805R
• Device Lot Number: 52459504
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1