MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 APPLYING FORCEPS NON-DETACH; CRANIOFIX 2 IMPLANTS

Model Number FF494R

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: 9610612-2018-00210, 9610612-2018-00189, 9610612-2018-00190, 9610612-2018-00191.

Manufacturer Narrative

Investigation: used test and analysis equipment: panasonic dmc tz8 digital camera.First we made a visual inspection of both instruments.Except some scratches and small dents, we found no abnormalities.The mechanism of both instruments is running smoothly without any ticking or jamming.Our technical services department then investigated the device and concluded that the function and parameters are all within specification.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: the instruments shows no signs of jamming, sticking or other malfunction.The check in the technical service department exhibits no functional deviations.No capa is necessary.

• Brand Name: CRANIOFIX 2 APPLYING FORCEPS NON-DETACH
• Type of Device: CRANIOFIX 2 IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7478099
• MDR Text Key: 107081268
• Report Number: 9610612-2018-00210
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF494R
• Device Catalogue Number: FF494R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2018
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other