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

Model Number FF490T

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap (b)(4) 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: 9610612-2021-00461 ((b)(4)+ ff490t).

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 1572 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
• Type of Device: CRANIAL FIXATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12021402
• MDR Text Key: 265655352
• Report Number: 9610612-2021-00460
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 04038653379569
• UDI-Public: 4038653379569
• Combination Product (y/n): N
• PMA/PMN Number: K122353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: FF490T
• Device Catalogue Number: FF490T
• Device Lot Number: 52332402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1