MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM; RANIOFIX RESORBABLE IMPLANTS

Model Number FF017

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).Suture knot did not work and disks was not fixed.

Manufacturer Narrative

Investigation: used test and analysis equipment: panasonic dmc tz8.First we made a visual inspection of the inplant system.Except the soiling we noticed no abnormalities.The treads were all in the prescribed position and the roeder knot is intact.In the next step we tried to pull the thread through the knot.This was not possible (as the complaint described).Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand the last three years.Conclusion and root cause: the root cause is most probably manufacturing related.Rational: the roeder knot seems tightened too firmly, so it does not work as intended.No capa is necessary.

• Brand Name: 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM
• Type of Device: RANIOFIX RESORBABLE IMPLANTS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7462962
• MDR Text Key: 106715210
• Report Number: 9610612-2018-00204
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• PMA/PMN Number: K040080
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: FF017
• Device Catalogue Number: FF017
• Device Lot Number: 52375009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Distributor Facility Aware Date: 04/23/2018
• Device Age: 5 MO
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other