MAUDE Adverse Event Report: AESCULAP AG ENNOVATE FRI DOWNTUBE SHORT; SPINE SURGERY

Model Number	SZ405R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a sz405r-ennovate fri downtube short (part # sz405r) was used during a procedure performed on an unknown date.According to the complainant, the operation was performed without any complications or problems.After the operation, the surgeon disconnected the tubes, according to the surgical procedure using the sz380r instrument.During the follow-up x-ray examination, a broken piece from the sz405r instrument was identified in the patient.Reoperation was performed and the part was removed.The patient was not injured.The complaint device was returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event / malfunction 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: the instrument arrived with broken off catch nose.The broken off nose was enclosed.Investigation was carried out visually and microscopically.Except the broken off tip of one catch, we found no further damages or deviations.In additon we found the typically signs of a forced intercrystalline fracture.Without further information about the circumstances of the loss, based on our experience we assume that the surgeon spread the downtube not completely with the removal key as mentioned in the instruction for use (ifu), so that the gripper bent during removal from the screw.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 3(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: ENNOVATE FRI DOWNTUBE SHORT
• Common Device Name: SPINE SURGERY
• 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: 12760394
• Report Number: 9610612-2021-00695
• Device Sequence Number: 3439601
• Product Code: LXH
• UDI-Device Identifier: 04046964719578
• UDI-Public: 4046964719578
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: SZ405R
• Device Catalogue Number: SZ405R
• Device Lot Number: 52558971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown