MAUDE Adverse Event Report: AESCULAP AG ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM; SPINE SURGERY

Model Number FJ933T

Device Problem Device Damaged by Another Device (2915)

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

Event Date 04/07/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with fj933t - abc self-locking cervical screw 4.0x16mm.According to the complaint description, during an unspecified orthopedic surgery, metal debris were found around the plate after placement.Screws had also been installed; all implants remained and the debris was removed.The procedure was completed successfully.An additional medical intervention was required.The adverse event is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) - fj934t (9610612-2022-00113), (b)(4) - fj934t (9610612-2022-00114).

Manufacturer Narrative

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

Manufacturer Narrative

Updated: d9 product return.Investigation results: visual investigation: we made a visual inspection of the both provided shavings.The color of the shavings is blue, so that we confirm, that the material is most probably shaved off from a abc- screw.Unfortunately, it is not possible for us to assign the shavings to a specially type of screw.Batch history review: the device quality and manufacturing history records have been checked for all the leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Review of the complaint history revealed that there are no similar complaints filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 5(10) x probability of occurrence 6(10) according to din en iso 14971 is still acceptable.Explanation and rationale: without further knowledge about the circumstances we assume, that the surgeon drilled the screw holes not centered to the plate hole/inserted the screws non-centered to plate hole, so that a part of the screw thread sheared off at the edge of plate.Conclusion and measures / preventive measures: based upon the investigation results, a clear conclusion cannot be determined.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Associated medwatch reports: (b)(6) - fj933t (9610612-2022-00112).(b)(6) - fj934t (9610612-2022-00113).(b)(6) - fj934t (9610612-2022-00114).

• Brand Name: ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM
• 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: 14225194
• MDR Text Key: 290287562
• Report Number: 9610612-2022-00112
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FJ933T
• Device Catalogue Number: FJ933T
• Device Lot Number: 52727095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• 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: Female