MAUDE Adverse Event Report: AESCULAP AG 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM; COVER, BURR HOLE

Model Number	FF017
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a 6 craniofix burr hole clamp absorb.16mm (part # ff017) was used during a procedure performed on (b)(6) 2021.According to the complainant, following the surgery, brain swelling occurred, which pushed the flap up from within the skull and led to the absorbable coming off.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made 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
Correction / addtional information: a2 & a3: patient information.H6: codes.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM
• Common Device Name: COVER, BURR HOLE
• 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: 12820813
• Report Number: 9610612-2021-00722
• Device Sequence Number: 5568516
• Product Code: GXR
• UDI-Device Identifier: 04038653347988
• UDI-Public: 4038653347988
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040080
• 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): 04/01/2022

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: FF017
• Device Catalogue Number: FF017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female