MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X35MM CANULATED; SPINE SURGERY

Model Number SY001TS

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that two (2) ennovate set screws (part # sy001ts) were used during a procedure performed on (b)(6) 2021.According to the complainant, the set screw was damaged while fastening with a parsuader.A new ennovate set screw (ref.Mdr id 9610612-2021-00532) was used, but the same issue recurred.The procedure was completed using a third screw.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Additional information has not been made available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00532_mdr (400520951 + sy001ts).Involved components: sy632ts - ennovate polyax.Screw 6.5x35mm canulated - 52534620.

Manufacturer Narrative

Associated medwatch-reports: 9610612-2021-00532_mdr (400520951 + sy001ts).Leading device.Reference code (b)(4), device name ennovate set screw sterile, serial number, batch number 52622950.Manufacturing date 27.07.2020.Reference code (b)(4), device name ennovate set screw sterile, serial number, batch number 52663512, manufacturing date 22.01.2021.Reference code device name: (involved component), sy632ts ennovate, polyax.Screw, 6.5x35mm canulated.Investigation: used test- and analysis- equipment: microscope "keyence- vhx 5000 " eq.-nr.2000024840.Digital-camera "panasonic dmc tz8".We made a visual inspection of the received four set- screws.At first we investigated the hexagon of screw "a".The hexagon of this screw exhibit no signs of wear or damages which were signs for a not correct applied hex- key.In the next step we investigated the bottom of the screw.Here we found unusual circular wear at the edge of the bottom, caused by a tilted applied rod.Then we investigated the hexagon of screw "b".Here we found no signs of wear or damages.The bottom of screw "b" exhibit nearly the same signs as screw a.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: the wear pattern on the bottom of the set screws are a sure hint for tightening the screws over a not correct (tilted) applied rod.A material failure or a manufacturing error can be excluded.Conclusion and root cause: due to the current deviation and according to explanation and rationale, the root cause of the problem is usage-related.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa request necessary.Associated medwatch-reports: 9610612-2021-00532_mdr (400520951 + sy001ts).

• Brand Name: ENNOVATE POLYAX.SCREW 6.5X35MM CANULATED
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12284282
• MDR Text Key: 265657136
• Report Number: 9610612-2021-00531
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046964989728
• UDI-Public: 4046964989728
• Combination Product (y/n): N
• PMA/PMN Number: K180433
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY001TS
• Device Catalogue Number: SY001TS
• Device Lot Number: 52534620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SY632TS - 52534620