MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MIS SCREWDRIVER SHORT; SPINE SURGERY

Model Number SZ381R

Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)

Patient Problems Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with ennovate mis screwdriver.According to the description text the ennovate mis screwdriver sz381r conducts no more force during use, and about 50% screw depth, the screws had to be screwed in with a s4 screwdriver, replacement is already done this event/malfunction prolonged the surgery for 60 minutes.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference 100026427/400486374.Invovled component sy865ts-polyax.Screw-52412120.

Event Description

Additional intervention was necessary to preclude permanent patient damage.Reevaluation of event changed from malfunction to adverse event.Medical intervention: cranial connection instability with existing s4+plif spondylodesis lkw 4/5.The or was successfully completed.

Manufacturer Narrative

B1, b2, b5 updated.Investigation results: visual investigation: in the first step, we made a visual inspection of the tip of the screwdriver and the interface in the screw head.The tip of the screwdriver is in a proper condition, without any wear or deformation.The interface of the screw is in a good condition too.And shows only slight wear.In the next step, we coated the screwdriver tip with a small film of spotting color, and put it in the screw head to make the contact pattern visible shows the color marks at the contact points.The contact between tip of the screwdriver and the screw head is sufficient.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed, that no similar complaints have been filed against products from this batch number.Conclusion and measures/preventive measures: based upon the investigation results, a clear root cause conclusion cannot be drawn.There is no indication, for a material, manufacturing or design-related failure.Based upon the investigations results, there is capa is not necessary.

• Brand Name: ENNOVATE MIS SCREWDRIVER SHORT
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10627191
• MDR Text Key: 209800705
• Report Number: 9610612-2020-00609
• 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
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: SZ381R
• Device Catalogue Number: SZ381R
• Device Lot Number: 52551106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SZ381R-52551106; SZ381R-52551106; SZ381R-52551106
• Patient Outcome(s): Required Intervention