MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 20MM; CRANIAL IMPLANTS

Model Number FF492T

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with craniofix.According to the customer description the clamp came off when the skull was fixed and the pin was finally cut with a cutter.No patient harm was noted.Additional information will be requested.Additional patient information is not available.The malfunction is filed under (b)(4).

Event Description

Additional information received, that we have a concomitant component with the articel number ff103r (pin cutter).

Manufacturer Narrative

B5 - addition of concomitant component, pin cutter used to remove pin (original description: the clamp came off when the skull was fixed and the pin was finally cut with a cutter).General information: intra operative incident.Up to now there is no product available for analysis.Consequences for the patient: according to the available information there were no negative consequences for the patient.Investigation: no product at hand.Only pictures received, which described in rationales.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There is no further complaint with this lot at hand.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: without a product available for analysis it is very difficult to make a reliable statement.As seen in the provided pictures - the cutting edges of the pin rest and the pin at the lower disc don't fit together.The spring segments of the come off upper disc appear bent uneven.This and the skewed cutting of the rest pin can be a hint for a skewed attached disc.We assume the lower disc and the pin rest not belong together.The fact that there are no further complaints with this lot at hand and the device history recording is found to be according to the specification we assume an usage related error, as in many previous complaints of the same type we investigated with products in the past.A material failure or a manufacturing error can be excluded.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

Manufacturer Narrative

Investigation results: the device was received for investigation.The implant arrived in a detached condition, the pin was cut and the upper disc was loosened from the pin rest of the lowe disc.Investigation, especially of the cutting edges of the pin and the spring segments of the upper disc, was carried out visually.The spring segments of the upper disc are bent uneven.The juxtaposition of the cutting edges produce the evidence that the pin rest and the lowe disc belong together.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There is no further complaint with this lot at hand.The root cause of the problem is most probably usage related.The spring segments of the come off upper disc appear bent uneven.This is a hint for a skewed attached disc.Against our assumption in the previous report ("we assume the lower disc and the pin rest not belong together") prove that the pin rest and the lower disc belong together.We assume an usage related error.A material failure or a manufacturing error can be excluded.A capa is not necessary.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9929251
• MDR Text Key: 186729286
• Report Number: 9610612-2020-00117
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K040864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 52540936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FF103R - UNKNOWN; FF103R - UNKNOWN