MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI DERMATOME; LARGE BONE POWER SYSTEMS

Model Number GA670

Device Problem Failure to Cut (2587)

Patient Problem Abrasion (1689)

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 ga670 - acculan 3ti dermatome.According to the complaint description, the device gripped the skin intraoperatively.Patient harm was unknown.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

After review of the investigation results, the complaint was re-assessed and found to no longer be reportable; pra was adjusted and severity was decreased to 2(5).Investigation: the investigation has been carried-out by the aesculap technical services (ats).The investigation showed that the plate ga670258 and measurement bar gb229415 have several damages.The axle ga643222 is damaged.Batch history review: since a repair was performed and this was identified as the cause, a review of the device history records is not necessary.The current failure rate is within the risk analysis and therefore acceptable; severity 2(5) and probability x(5).Explanation and rationale: a clear conclusion cannot be drawn.The damages at the plate ga670258 and measurement bar gb229415 are probably originated by falling or impact, possibly this has led to a misalignment of the dermatome head.Since the maintenance date has to be carried out in august 2022, it could be possible that wear and tear and / or a lack of maintenance led to the described problem.However, this is only speculative.Conclusion/preventive measures: based on the investigation results, a capa is not necessary.

• Brand Name: ACCULAN 3TI DERMATOME
• Type of Device: LARGE BONE 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16807490
• MDR Text Key: 313930306
• Report Number: 9610612-2023-00082
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA670
• Device Catalogue Number: GA670
• Device Lot Number: 52465714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1