MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM; CRANIAL FIXATION

Model Number	FF490T
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a craniofix 2 titanium clamp 11mm (part # ff490t) was opened prior to use.According to the complainant, the package glue was noted as being too tight causing it to tear when opened.The reporter alleged that the product did not remain sterile.The complaint device was returned to the manufacturer for evaluation.No patient involvement.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00460 (b)(4) + ff490t).
Additional Manufacturer Narrative
Investigation results visual investigation: the investigator made a visual inspection of the blisters and the sealing foil.The secondary sealing foil of the complained part out of the lot number 52332402 seems to be brittle and very wavy.The secondary sealing foil of the complained part out of the lot number 52344615 seems not so brittle but teared during the peeling off in a not intended way, likewise the foil of the primary blister.In the next step we made an investigation of the lot of the used peel foil.Furthermore here we found no abnormalities.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification 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.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: without further knowledge about the circumstances we assume the storage conditions of the complained products as the root cause of the problem.Each lot contains (b)(4) units and these complaints are the only ones about these two lots.The production records showing no hints for a production or material failure.Based upon the investigations results a capa is not necessary.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 11MM
• Common Device Name: CRANIAL FIXATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12021323
• Report Number: 9610612-2021-00461
• Device Sequence Number: 17302267
• Product Code: GXN
• UDI-Device Identifier: 04038653379569
• UDI-Public: 4038653379569
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K122353
• 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): 09/22/2021

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: FF490T
• Device Catalogue Number: FF490T
• Device Lot Number: 52344615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1