MAUDE Adverse Event Report: AESCULAP AG TUNNELING INSTRUMENT 300MM; HYDROCEPHALUS MANAGEMENT

Model Number	FV002R
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a tunneling instrument 300mm (part # fv002r) was used during a procedure performed on (b)(6) 2022.According to the complainant, the tip did not penetrate during surgery.During the vp shunt operation, the physician tried to insert a tunneler from the back of the pinna to the clavicle, but it did not penetrate.The device tip remained in-situ.The surgeon attempted to remove the tip, but was not able to remove it and decided to remove it.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.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: visual investigation: the analysis of the damage pattern showed a shear fracture due to overload.No pores, inclusions or foreign bodies could be found at the damage site.In addition, the damaged distal end of the fiber and of the tip are an indicator of improper use during application, most likely caused by movement during positioning.Batch history review: the device quality and manufacturing history records (dhr) have been checked for the leading device(s) lot number(s) and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.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.Explanation and rationale: due to the damage pattern the shearing of the fibre was most likely caused by a tilt of the fibre during the positioning of the instrument.By pulling the whole instrument back during positoning, the tip of the fiber can lift out of the tube.During the following forward movement the tip can be sheared off by force on the tube.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 on the investigation results, a capa is not necessary.

• Brand Name: TUNNELING INSTRUMENT 300MM
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• 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: 13655284
• Report Number: 9610612-2022-00041
• Device Sequence Number: 20278823
• Product Code: HAO
• UDI-Device Identifier: 04038653342600
• UDI-Public: 4038653342600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/18/2022

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 Expiration Date: 07/19/2026
• Device Model Number: FV002R
• Device Catalogue Number: FV002R
• Device Lot Number: 52704056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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