MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 20MM; CRANIAL IMPLANTS

Model Number	FF492T
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with ff492t-craniofix 2 titanium clamp 20mm.According to the complaint description, the surgeon used craniofix to fix his bone flap.He tightened it to hold it in place but when he cut the stem, the top of the craniofix jumped off.This event/malfunction prolonged the surgery for 20 minutes.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Additional Manufacturer Narrative
Additional information - b5, d4 (udi), e1.Corrected information - b1, b2, d9, h1.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: 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.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.The provided implant is in original sealed blister.The defect / complained product is not available for analysis.
Event or Problem Description
Additional information was received which revealed that "the surgeon used craniofix to fix his bone flap.He tightened it to hold it in place, but when he cut the stem, the top of the craniofix jumped off." subsequently, the physician had to use "more craniofix." an additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Common Device Name: CRANIAL IMPLANTS
• 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: 13047805
• Report Number: 9610612-2021-00712
• Device Sequence Number: 19189356
• Product Code: GXN
• UDI-Device Identifier: 04038653379606
• UDI-Public: 4038653379606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K972332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: 09/12/2026
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 52714385
• 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: 11/26/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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 Sex: Unknown