MAUDE Adverse Event Report: AESCULAP AG ABC SELF-LOCKING ASSISTANCE; SPINE SURGERY

Model Number FJ911R

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2019

Event Type  Injury  

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 abc self-locking assistance.It was reported that 10 screws were well engaged into the abc plate and the surgeon checked each screw to see locking pins were elevated.One screw in right c7 showed that the locking pin ws not elevated.The surgeon attempted to correct insertion depth of the screw in question, using a usual screw-driver, but the screw-driver would not fit the screw, although there was no problem previously.Secondly, the surgeon tried to pull up the locking pin using self-locking assist (fj911r) , however when pulling up the instrument, its tip was broken apart where it was connected to the screw, and the broken tip was stuck in the screw head.For the third time, he tried to remove the screw using abc screw-out sleeve (fj912r) , with no success.He attempted some other ways to remove the screw, with no success.Finally the surgeon decided to leave the screw in situ, as, per the post-operative x-ray exam showed that all the ten screws were engaged in the plate holes.The screw in question is not available , as it is in the patient.The broken tip remained in the patient.Additional information was not provided nor available / was not available.The adverse event is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00852 ((b)(4) fj932t).

Manufacturer Narrative

Associated medwatch reports: 9610612-2019-00852 (400455955 fj932t).Manufacturing site evaluation: the instrument arrived in a decontaminated condition.Investigation: the threaded tip of the instrument is broken off.The broken off tip is missing.Used test and analysis equipment: microscope "keyence: vhx 5000 " eq.-nr.2000024840.Digital camera "panasonic dmc tz8".We made a visual inspection of the fracture surface.Here we found the typically signs of a multi axial stress condition of bending and torsion.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.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: the fracture surface shows the typically signs of a fracture caused by mechanical overload (bending in conjunction with torsion).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.Batch number, date received by manufacturer and production date could be determined after receipt of the article.

Event Description

Batch number, date received by manufacturer and production date could be determined after receipt of the article.

• Brand Name: ABC SELF-LOCKING ASSISTANCE
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9527628
• MDR Text Key: 174280645
• Report Number: 9610612-2019-00851
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FJ911R
• Device Catalogue Number: FJ911R
• Device Lot Number: 52307617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR