MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SCREW DRIVER; NSTRUMENTS POSTERIOR STABILISION

Model Number SZ262R

Device Problem Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results: the screw driver arrived with broken off tip.The broken off tip was not enclosed.At first we made a visual inspection of the complete instrument.Except the broken off tip we found no damages or abnormities.In the next step we made a microscopically inspection of the fracture surface.Here we found the typically sings of a intercrystalline torsion fracture.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There is one further complaint with this lot at hand.The root cause for the problem is most probably usage related.The fracture surface shows the typically signs of a mechanical overload.Without further knowledge about the circumstances we suspect that the screwdriver was not correct attached or rather correct fastened (union nut) to the head of the pedicle screw.The ifu points out, that it is necessary, to connect and fasten the screwdriver correctly at the screw.A capa was not initiated.

Event Description

It was reported that there was an issue with a ennovate screw driver.During the surgery, an 8.5 ennovate screw could no longer be screwed in.It was extremely fixed.The screwdriver at the tip of the screw broke off.Now it was only possible to provide the screw with a rod and a locking nut and thus turn the whole screw.However, the screw did not move.Now the screw should be unscrewed in this way, because it was still far away from its position and was too high.When turning it back, the body has turned off the shaft.The unscrewing of the stock didn't work with the set screw screwdriver, it deformed at the tip and the screw had to be removed.The adverse event is filed under aag reference (b)(4).Involved component (is not sold to us): sy865ts - ennovate polyax.Screw 9.5 x 50 mm fenestr.Batch: 52412120 (b)(4).Associated medwatch reports: 9610612-2019-00623 (b)(4) - sz391r.

• Brand Name: ENNOVATE SCREW DRIVER
• Type of Device: NSTRUMENTS POSTERIOR STABILISION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9071765
• MDR Text Key: 158950850
• Report Number: 9610612-2019-00622
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2019

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: SZ262R
• Device Catalogue Number: SZ262R
• Device Lot Number: 52396891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention