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

Model Number	FF016
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	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 ff016 - 6 craniofix absorbabl.Clamp sterile 11mm.According to the complaint description, the wire broke during surgery.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information: d9 investigation results visual investigation we made a visual inspection of the received parts.The thread holes in the discs exhibit no sharp edges.The roeder- knot works as intended, no excessive force was required to move the knot on the thread.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 one similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: without further knowledge about the circumstances and with the lack of information we assume, that the surgeon applied abrupt a too high force on the implant during insertion / tightening.A further possible root cause is the usage of some sharp edged instruments during application.A material defect or a manufacturing error can be excluded.Based upon the investigations results a capa is not necessary.

• 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
• MDR Report Key: 11693287
• Report Number: 9610612-2021-00353
• Device Sequence Number: 3128740
• Product Code: GXR
• UDI-Device Identifier: 04038653347971
• UDI-Public: 4038653347971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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 Expiration Date: 02/21/2024
• Device Model Number: FF016
• Device Catalogue Number: FF016
• Device Lot Number: 52490174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1