MAUDE Adverse Event Report: AESCULAP AG S4 SCREW; BONE SCREW FOR POSTERIOR STALIZATION

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.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 s4 element mis rod caliper during surgery.On (b)(6) 2018, the patient underwent a lumbar fusion.When the surgeon placed the rod caliper in the down tube to measure rod length, it would not come out.The surgeon eventually used a mallet to remove it, and then the saddle from the screw came out with it.The tip of the rod caliper had lodged into the female part of the saddle, and that part of the screw came out with the caliper.A five minute delay in surgery was noted.There was no injury to the patient and no additional medical intervention required.Additional details regarding clarification of the event were provided on (b)(6) 2018.Details: inside the pedicle screw there is a "saddle" where the rod sits.The rod caliper got lodged into the saddle and when the surgeon pulled the caliper out, the saddle came out with it.He removed the screw and replaced it with a new screw.The caliper was not damaged and no fragments were left in the patient.There were no adverse outcomes, it took approximately 5 minutes to remove and replace the screw.This report addresses the malfunction of the screw.Associated medwatches: 9610612-2018-00604 ; 9610612-2018-00620 (this report).

Manufacturer Narrative

Corrected data: b1, d4, h4.Investigation.In the first step, we made a visual inspection of the instrument, especially the tips of the measuring pins.Her we found no abnormities or damages like bending dents or burrs.In the next step, we measured the diameter of the measuring pins.According to the drawing, the diameter of the pin must be 4,75mm (+/- 0,01mm according din iso 2763-1).Pin "a" was measured with 4,78mm, pin "b" was measured with 7,75.Therefore, both pins are within their specification.Batch history review.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause.The root cause for the problem is most probably usage related.Rationale.For the described problem, relevant dimensions of the instrument are within their specifications.Furthermore, there are no damages like bending or burrs visible.Without further knowledge about the circumstances we assume, that the insert of the concerned screw was loosened during screwing the screw into the pedicle.During the measuring the complained instrument, the loosened insert is stuck at the tip of the rod caliper.No capa is necessary.

Manufacturer Narrative

Corrected data: b1, d4, h4.Investigation: in the first step, we made a visual inspection of the instrument, especially the tips of the measuring pins.Her we found no abnormities or damages like bending dents or burrs.In the next step, we measured the diameter of the measuring pins.According to the drawing, the diameter of the pin must be 4,75mm (+/- 0,01mm according din iso 2763-1).Pin "a" was measured with 4,78mm, pin "b" was measured with 7,75.Therefore, both pins are within their specification.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: for the described problem, relevant dimensions of the instrument are within their specifications.Furthermore, there are no damages like bending or burrs visible.Without further knowledge about the circumstances we assume, that the insert of the concerned screw was loosened during screwing the screw into the pedicle.During the measuring the complained instrument, the loosened insert is stuck at the tip of the rod caliper.No capa is necessary.

• Brand Name: S4 SCREW
• Type of Device: BONE SCREW FOR POSTERIOR STALIZATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8200006
• MDR Text Key: 132390285
• Report Number: 9610612-2018-00620
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/18/2018
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOWN TUBE.; MALLET.; ROD CALIPER.