MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MULTIAX.CROSS CONN.45-58MM STER; ENNOVATE IMPLANTS

Model Number SX937TS

Device Problem Product Quality Problem (1506)

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

Event Date 01/22/2021

Event Type  malfunction  

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 sx937ts - ennovate multiax.Cross conn.45-58mm ster.According to the complaint description, after opening the cross connector, when loosening the three screws, one screw on one side of the side was hard and did not loosen.The screwdriver turned, but every joint turned, and only the screw on one side protruded greatly.After that, another new product of the same size was opened and used.This time, all parts were loosened without any problems.The surgery was completed without any problems.Surgeon's comment: "i want you to loosen the screws a little more before sterilization".There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: we made a visual inspection of the implant.Here we found no defects or damages, the center screw is tightened, the outer screws are loose.The implant shows no deviation to the functionally specification.The torque which was affordable to open the middle screw corresponds to the torque of the pre fixation during the manufacturing.The error described in the complaint could not be confirmed in the course of the analysis.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.Conclusion and measures / preventive measures: based upon the investigation results no failure was detected.There is no indication for a material-, manufacturing- or design-related failure.The product is according to the specifications.Based upon the investigations results a capa is not necessary.Based upon investigation results, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: ENNOVATE MULTIAX.CROSS CONN.45-58MM STER
• Type of Device: ENNOVATE IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11339145
• MDR Text Key: 253235330
• Report Number: 9610612-2021-00085
• Device Sequence Number: 1
• Product Code: NKB
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SX937TS
• Device Catalogue Number: SX937TS
• Device Lot Number: 52603211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1