MAUDE Adverse Event Report: AESCULAP AG 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM; CRANIAL FIXATION

Model Number	FF016
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with ff016 - 6 craniofix absorbabl.Clamp sterile 11mm.According to the complaint description, the device was damaged in the lower disc and the bone flap was lifted, so surgery was performed again.No infection.A revision surgery was necessary.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation: visual investigation carried out pictorial documentation visually and microscopically.Some fragments of craniofix-absorbable arrived in a contaminated condition in a poly bag.This investigation did not allow any conclusions to be drawn about the cause of breakage.In the next step we made a historical dat analysis and a check of the device history record of another lot.Again, we found no evidence of process or product deviations that could lead to damage like the one received.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.The failure mode is not considered in the risk analysis, therefore, the analysis will be adjusted.Explanation and rationale: without further knowledge about the circumstances we assume that the surgeon applied a too high force onto the implant during the implantation.Only once case occurred in the last five years and the production lot of the craniofix has a volume of more than 6000 pcs.Therefore a material defect or a production error can be excluded.Conclusion and root cause: due to the current deviation, and according to explanation above, the root cause of the problem is most probably usage-related.Corrective action: a capa is not necessary.Concerning the missing failure pattern in the risk analysis, a product safety case (psc) was launched.

• Brand Name: 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM
• Common Device Name: CRANIAL FIXATION
• 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: 11314669
• Report Number: 9610612-2021-00070
• Device Sequence Number: 715008
• Product Code: GXR
• UDI-Device Identifier: 04038653347971
• UDI-Public: 4038653347971
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: FF016
• Device Catalogue Number: FF016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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