MAUDE Adverse Event Report: AESCULAP AG ABC SELF-LOCKING REVISION SCREW 4.5X17MM; IMPLANTS CERVICAL STABILISATIO

Model Number FJ943T

Device Problem Device Damaged by Another Device (2915)

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

Event Date 06/30/2022

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 fj943t - abc self-locking revision screw 4.5x17mm.According to the complaint description, the screw was damaged.During the surgeries of the abc plate, the doctor had to re-install the screw several times when putting in the last one.As a result, doctor changed to an oversize screw because a thin screw would loosen.When it was inserted, it swung too far to the head side and had to be removed again.After removed it, the doctor found that there was a something in the screw hole, so the doctor took it out and found a round wire-like object.Also, upon closer inspection of the screw, the threads were missing and it appeared that the threads had been stripped.A different screw was installed and the ope was successfully completed.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: we made a visual inspection of the screw and the chip.It is clearly visible, that the chip belongs to the damaged screw.The size and length of the chip correspond to that of the missing threads.We also noticed that the head of the screw and the petals on the flanks are deformed.Device history records: 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 are currently no further complaints with this lot and error pattern at hand.The current failure rate is within the risk analysis according to din en iso 14971 is still acceptable; severity was 5(10) and probability 6(10).Explanation and rationale: according to the op manual and the ra, such errors can occur if the screw holes are not drilled centrically to those of the plate.The thread scrapes the edge of the hole in the plate and, in the worst case, can peel off.If the screw is screwed in further, the screw head and the petals will also be deformed.Conclusion and preventive measures: based upon the investigation results, a clear root cause could not be determined, but is likely a handling error.Based upon the investigation results, a capa is not necessary.

Event Description

The adverse event is filed under aag reference (b)(4).

• Brand Name: ABC SELF-LOCKING REVISION SCREW 4.5X17MM
• Type of Device: IMPLANTS CERVICAL STABILISATIO
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15052063
• MDR Text Key: 296139767
• Report Number: 9610612-2022-00199
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050813
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FJ943T
• Device Catalogue Number: FJ943T
• Device Lot Number: 51753105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male