MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SCREW TAP F/D4.5MM; SPINE SURGERY

Model Number SZ254R

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/26/2019

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 ennovate screw tap f/d4.5mm.It was reported that the tap broke during removal from vertebral body s1.The broken working end could be removed completely.The broken piece was removed with a special removal set which was used against the drilling direction.It was an spondylolisthesis surgery.The surgery was finished successfully and the patient is well.This event prolonged the surgery for 30 minutes.Additional information was not provided.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: the instrument arrived in a decontaminated condition.Surgery delay was longer than 15 minutes.The instrument arrived with broken off tip.The broken off tip was enclosed.Used test- and analysis- equipment: · microscope "keyence- vhx 5000 " eq.-nr.2000024840; · digital-camera "panasonic dmc tz8".At first we made a visual inspection of the dimensions of the fracture pieces and compared the values with the construction drawing.Length of the shaft (long piece): 228 mm.Length of the broken off piece: 29,3 mm.Amount: 257,3 mm.Target value: 257,4 mm.Therefore we received all pieces of the instrument.Because of the secondary damages, caused by the recovery, a investigation of the fracture surface of the tip makes no sense, so in the next step we investigated the fracture surface on the shaft.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 exhibit the typically signs of a multi axial stress condition of bending and torsion.Without further knowledge about the circumstances, we suspect that the surgeon applied to high force to the instrument in conjunction with levering and bending.The instructions for use (ifu) points out, to avoid levering and bending during the threading.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: ENNOVATE SCREW TAP F/D4.5MM
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9476222
• MDR Text Key: 174276343
• Report Number: 9610612-2019-00853
• Device Sequence Number: 1
• Product Code: HWX
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SZ254R
• Device Catalogue Number: SZ254R
• Device Lot Number: 52396703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention