MAUDE Adverse Event Report: AESCULAP AG ENNOVATE ROD PERSUADER; SPINE SURGERY

Model Number SZ277R

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection - at first we performed out a visual inspection of the body (outer part) of both instruments, here especially the clamping arms and the catches which are responsible for a proper fixation of the screw in the instrument.The catches of instrument "a" both exhibit no signs of deformation or unusual wear.The clamping arms of instrument "a" are in a proper condition (not bent or deformed) and both are easy to operate.In the next step we investigated the sleeve of the instrument "a".The both parts (inner and outer sleeve) are detached at the connection point.The snap ring of the inner sleeve is still in its position but the blue peek- ring which is positioned in the outer sleeve is missing.After that we made the same investigation steps at instrument "b" with absolutely the same results.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 is one similar complaint against the lot 52378266.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: without further knowledge about the circumstances we assume, that the disconnection between the outer and the inner sleeve occurred during trying pulling out the sleeve out of the instrument with too high force while something was stuck.Neither the catches nor the interface of the one received pedicle screw (involved component) show deformation or strong wear, which could be a hint for a connecting / disconnecting problem.Unfortunately the instrument arrived qmv with disconnected screw (most likely the screw was detached in our decontamination process).We informed r&d about the problem with the detached sleeves.A material failure or a manufacturing error can be excluded.Conclusion and root cause: due to the current deviation and according to the information above, the root cause of the problem is most probably usage-related.R&d want to check whether there is a possibility of improving the dimensions in the area of the ring ni order to make similar incidents even less likely and make the instrument more robust.A capa is not necessary.

Event Description

It was reported that there was an issue with sz277r - ennovate rod persuader.According to the complaint description, intraoperatively, the screw would not loosen from the instrument.An additional medical intervention was required.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch reports: (9610612-2022-00052) (b)(4) - sz277r, lot 52378266; (b)(4) - sz277r, lot 52412234.Involved components: sy145ts - ennovate polyax.Screw 7.5x50mm solid, lot 52618037.

• Brand Name: ENNOVATE ROD PERSUADER
• Type of Device: SPINE SURGERY
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13620614
• MDR Text Key: 288619373
• Report Number: 9610612-2022-00053
• Device Sequence Number: 1
• Product Code: LXH
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SZ277R
• Device Catalogue Number: SZ277R
• Device Lot Number: 52412234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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
• Treatment: SY145TS - LOT 52618037
• Patient Outcome(s): Required Intervention