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

Model Number SZ277R

Device Problem Mechanical Jam (2983)

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

Event Type  Injury  

Event Description

It was reported that there was an issue with the product sz277r - ennovate rod persuader.According to the complaint description, the rod persuader would not release off the screw and seemed to be stuck.Another instrument was used to pry them apart.An additional medical intervention was required.Additional details were not provided, but had been requested.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Investigation results: the instrument arrived in detached condition; the inner persuader was detached in two pieces.Visual and microscopic investigation was made of all provided parts.The clamping mechanism ran smoothly, both legs were not bent and able to release completely and easily.The threaded upper part was also examined.No damages or deformation were found.The lower part showed no deformation; the snap-ring was in in its correct position, but the peek washer was missing (positioned above the snap ring).Batch history review: the device quality and manufacturing history records 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.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: the cause of the problem described could not be conclusively clarified.Except for the detached persuader tip, the instrument shows no defects, deformation or excessive wear, which could lead to a problem such as documented in the complaint description.Since the snap ring is still in place, the detachment of the persuader front part is definitely due to excessive force.Also, usually the peek washer (unsplintered) cannot be removed as long as the snap ring is still in its position.Based upon the investigation results, a capa is not required.

• 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: 18276862
• MDR Text Key: 329855034
• Report Number: 9610612-2023-00261
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: SZ277R
• Device Catalogue Number: SZ277R
• Device Lot Number: 52468954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• 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