MAUDE Adverse Event Report: AESCULAP AG IMPLANT INSERTER/MANIPULATOR; INSTRUMENTS INTERBODY FUSION

Model Number ME015R

Device Problem Mechanical Jam (2983)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with the product me015r - implant inserter/manipulator.According to the complaint description, the implant inserter was defective; it would not tighten down on the implant.Another device was readily available to complete the procedure.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

Additional information: d9 - product return date.H3 - yes, evaluation.H4 - manufacture date.H6 - codes updated.Investigation results: a visual and microscopic investigation of the received instrument was performed.The cranial and caudal side of the instrument interface showed no damages or signs of excessive wear.The tips of the imstrument's implant mounts showed no signs of deformation, bending, or wear.The joint of the clamping mechanism ran smoothly and showed no malfunctions like sticking or jamming.The instrument was then disassembled and joints and threads of joints investigated.No signs of defects or damaged threads were found; these could have caused problems like jamming or sticking of the mechanism.In the last step, the interface of the not-enclosed depth stop was checked.No deformations, wear or corrosion were found.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.Based on the production date 2014, it was possible to identify six batches for this period.This concerns the batches 52011290; 52024081; 52053443; 52082447; 81840890 and 52057596.There are no further complaints out of the mentioned batches at hand.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: on the basis of the available information as well as 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 investigation results, a capa is not required.

• Brand Name: IMPLANT INSERTER/MANIPULATOR
• Type of Device: INSTRUMENTS INTERBODY FUSION
• 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: 18276044
• MDR Text Key: 329848618
• Report Number: 9610612-2023-00258
• 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

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ME015R
• Device Catalogue Number: ME015R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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