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

Model Number	GA670
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that an acculan 3ti dermatome (part # ga670) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the device was used to cut a graft.Reportedly, the graft was complete, but uneven; the thickness of the graft was varying, which was abnormal.An additional graft needed to be taken to continue and complete the procedure.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: visual investigation: optically, the device is in a bad /strongly soiled condition.The investigation has been carried-out by the aesculap technical service (ats).The complete results can be found within pc notification (b)(4).According to our database, the product was manufactured in july 2012 and distributed in august 2012.The only registered repair/maintenance took place in november 2021.Due to the bad condition of the device, a functional test was not possible.It is possible that the reported failure occurred due to the bad overall condition.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.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.

• Brand Name: ACCULAN 3TI DERMATOME
• Common Device Name: 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13550412
• Report Number: 9610612-2022-00047
• Device Sequence Number: 17457043
• Product Code: GFD
• UDI-Device Identifier: 04046963406196
• UDI-Public: 4046963406196
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA670
• Device Catalogue Number: GA670
• Device Lot Number: 51865563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown