MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS CRANIOFIX 2 TITANIUM CLAMP 20MM; CRANIOFIX 2 IMPLANTS

Model Number FF492T

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: three products did not work properly.Therefore, all of the disks were removed.Three upper and three lower discs arrived in common with three pins.Two of the upper discs were bent.A visual inspection of the lower discs, especially the pins and their cutting edges.It appears a pin which was cut skewed and underneath the last rim, so the disc came off.The pin of the disc was cut skewed too ad the damages of the rims at one side are a hint for a not correct pushed down upper disc.It is assumed during removal the disc, it came to the deformation.The pin of the disc was cut skewed through a fixation rim, so the upper disc came out without damages.The manufacturing documents have been checked and found to be according to specification valid during the time of production.The root cause for the problem is most probably usage related.A material defect or a manufacturing error can be excluded.A capa is not necessary.

Event Description

Country of complaint: (b)(6).Three of products did not work properly.All med watch submissions related to this report are: 9610612-2018-00189; 9610612-2018-00190; 9610612-2018-00191.

Manufacturer Narrative

Investigation: used test and analysis equipment: keyence vhx 600 d digital microscope, panasonic dmc tz8 digital camera.We made a visual inspection of the lower discs, especially the pins and their cutting edges.Disc "a" exhibits a pin which was cut skewed and underneath the last rim, so the disc came off.The pin of disc "b" was cut skewed as well and the damages of the rims on one side are an indication of a incorrectly pushed down upper disc.We assume during removal of the disc, it became deformed.The pin of disc "c" was skewed through a fixation rim, so the upper disc came off without damages.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: a material defect or a manufacturing error can be excluded.No capa is necessary.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Type of Device: CRANIOFIX 2 IMPLANTS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7455913
• MDR Text Key: 106392497
• Report Number: 9610612-2018-00190
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K972332
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 52309188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2018
• Device Age: 10 MO
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other