MAUDE Adverse Event Report: AESCULAP AG CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM; CRANIAL IMPLANTS

Model Number	FM921T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 fm921t - cranioplate 1.5 scr.Mag.Cross l:4mm.According to the complaint description, there was screw breakage.There were broken nails and hairpins during the operation, which delayed the doctor's operation time.There was significant surgery delay.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the screws exhibit damages and deformation at the tip.We made a visual inspection of the single screws (hereinafter referred to as a - f).Screw "a" exhibit no damages or deformation.Screw "b" - "d" exhibit a flattened tip (not broken off !) and several damages at the thread.Screw "f" & "g" exhibit broken off tips.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 5 similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 6(10) x probability of occurrence 3(10)) 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: CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM
• Common Device Name: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12453926
• Report Number: 9610612-2021-00597
• Device Sequence Number: 16977325
• Product Code: JEY
• UDI-Device Identifier: 04038653463671
• UDI-Public: 4038653463671
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FM921T
• Device Catalogue Number: FM921T
• Device Lot Number: 52584299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1