MAUDE Adverse Event Report: AESCULAP AG HUMBY DERMATOME 365MM; BASIC INSTRUMENTS

Model Number BA713R

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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 ba713r - humby dermatome 365mm.According to the complaint description, the device bowed during surgery.This occurred around the area of the blade on the instrument.The patient's arm was lacerated.An additional medical intervention was required.The patient required suturing and a different technique was used to obtain the skin graft.Additional patient information is not available.The device was taken out of service.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: h6 codes updated.Investigation results: the product was sent to the manufacturer rudolf storz gmbh for the subject matter expert analysis.Following results: the instrument must have fallen down, but it is no longer possible to determine where.Batch history review: a review of the device history records for the complained device was requested but not possible.The review of risk assessment revealed that the overall risk level (severity 3(5) and probabiltity 1(5)) according to din en iso 14971 is still acceptable; the current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: the definitive root cause for the mentioned failure could not be determined exactly.According to the manufacturer investigation the product must have fallen down.Based upon the investigations results a capa is not necessary.

• Brand Name: HUMBY DERMATOME 365MM
• Type of Device: BASIC INSTRUMENTS
• 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: 14986087
• MDR Text Key: 295685216
• Report Number: 9610612-2022-00169
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BA713R
• Device Catalogue Number: BA713R
• Device Lot Number: 4511234033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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
• Patient Outcome(s): Required Intervention