MAUDE Adverse Event Report: AESCULAP AG QUINTEX SCREW REMOVAL TOOL; INSTRUMENTS CERVICAL STABILISATION

Model Number	SC433R
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with sc433r - quintex screw removal tool.According to the complaint description, the tip of the instrument broke during an anterior cervical discectomy and fusion (acdf) procedure.The surgeon needed to take a screw out after already putting it through the plate hole.This was done in order to attempt repositioning.There was some difficulty in removing the screw and it seemed to just come right out of the patient due to soft bone.The surgeon then tried to remove the screw from the plate on the mayo stand but was unsuccessful.The tip broke off into the screw head; this occurred away from the surgical field on the mayo stand.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
The complaint has been re-assessed based upon review of updated patient harm; it changed to "no patient hazard" after investigation.The initial reporting evaluation is no longer valid.Investigation results: we made a visual inspection of the instrument.Except the broken off tip, the instrument showed no damages or defects.In the next step, we investigated the fracture surface.Here we found the typical signs of an intergranular fracture and signs of a pre-damage.Batch history review: 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 no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level 5(10) severity x 4(10)probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: the root cause for the failure is most probably usage-related, respectively wear and tear related.The driver has a very fine threaded tip and the instrument at hand was in usage for eight(8) years.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results, a capa is not necessary.
Event or Problem Description
Clarification: there was no patient harm nor surgical delay.

• Brand Name: QUINTEX SCREW REMOVAL TOOL
• Common Device Name: INSTRUMENTS CERVICAL STABILISATION
• 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: 12050333
• Report Number: 9610612-2021-00474
• Device Sequence Number: 3464561
• Product Code: HXX
• UDI-Device Identifier: 04046963711863
• UDI-Public: 4046963711863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SC433R
• Device Catalogue Number: SC433R
• Device Lot Number: 51935419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown