MAUDE Adverse Event Report: AESCULAP AG SAW BLADE 23/0.25/0.35MM STERILE; POWER SYSTEMS

Model Number GC615R

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was an issue with gc615r - saw blade 23/0.25/0.35mm sterile.According to the complaint description, the surgeon cut off the mandible with a reciprocating saw blade.He noticed that the first serration on the anterior end of the saw blade had broken after use.The surgeon searched for the broken serration, but could not find it in the wound or on the table surface.Patient harm was unknown.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Additional information/correction: b5 - patient harm updated.B7 - type of procedure added.H6 - codes updated.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Potential trends and signals related to this article group and failure mode are monitored and if indicated product safety cases will be initiated according to mdr article 88.Explanation and rationale: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

Event Description

Update: patient harm changed from unknown to no patient hazard.

• Brand Name: SAW BLADE 23/0.25/0.35MM STERILE
• Type of Device: POWER SYSTEMS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16950665
• MDR Text Key: 315493594
• Report Number: 9610612-2023-00122
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GC615R
• Device Catalogue Number: GC615R
• Device Lot Number: 52795911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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