MAUDE Adverse Event Report: AESCULAP AG ENNOVATE ROD PERSUADER; INSTRUMENTS POSTERIOR STABILIS

Model Number SZ277R

Device Problems Device Damaged by Another Device (2915); Difficult to Open or Close (2921)

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

Event Type  Injury  

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 an ennovate rod persuader (part # sz277r) was used during a procedure performed on an unknown date.According to the complainant, during the surgery, the instrument was not able to be opened and it jammed with the screw head.The complaint device has not yet been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Correction / additional information: b1: "product problem changed" to "adverse event".B2: required intervention to prevent permanent impairement / damage.B5: patient harm changed from "no patient hazard" to "additional medical intervention necessary." g2: report source updated from "foreign" to "company representative." h1: serious injury.Investigation results: visual investigation: the instrument arrived detached in its single parts, the snap ring of the inner part is completely deformed.We carried out a visual inspection of the individual parts using microscope and digital-camera.The tip of the instrument with its interface shows no defects or bending, the levers of the latches are not bent and smooth running.The interface of the latches are in a proper condition, without bending or wear.The inner part of the persuader is torn apart, the snap ring, which holds the two parts together is bent and out of its position.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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.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 a capa is not necessary.

Event Description

Correction: patient harm changed from "no patient hazard" to "additional medical intervention necessary".An additional medical intervention was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.

• Brand Name: ENNOVATE ROD PERSUADER
• Type of Device: INSTRUMENTS POSTERIOR STABILIS
• 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: 13213657
• MDR Text Key: 289333163
• Report Number: 9610612-2021-00808
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04046964700927
• UDI-Public: 4046964700927
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• 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: 52597926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• 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