MAUDE Adverse Event Report: SYNTHES GMBH SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS

Catalog Number	03.610.602
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during a traumatological anterior cervical fixation the cervical spine locking plate (cslp)-variable angle (va) system with quicklock screws was used.Because the screwdrivers already showed signs of wear, they had been previously removed from the set and a pair of new ones were placed on the set instead.During the procedure, when it came to the next step of inserting the screws, the or scrub nurse could not insert the screwdriver into the screw (when it was resting in the screw tray).Both the operating surgeons tried to stick the screw onto the screwdriver but were unsuccessful.They could only insert the screwdriver into the screw if they held both pieces with their hands, however the retention was less than a fraction of a millimeter.Because this was insufficiently stable to be inserted, they had to use a backup and completed the procedure with the normal cslp screws and instruments.The screwdriver blades are too wide for the spaces in the screw and cannot be inserted into the screw.One of the screwdrivers was modified by the hospital in-house after the procedure in order to attempt a fix because there was another surgery lined up for the next day.This report is for one (1) self-retaining screwdriver for quick lock screws.This is report 1 of 3 for pc-(b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: the device received at hägendorf site ¿screwdriver f/quicklock screws¿ article number 03.610.602 with lot number 52p9784 is in used conditions.Few scratches are present on the device.However, even if the device was in use, it still looks able to properly function.Even if not required per selected investigation flow in order to perform the investigation, all the documents mentioned above, valid when the device was manufactured, have been analyzed.The manufacturing process was executed according to the analyzed documents and no anomalies were identified.According to evidence is not possible to address the final root cause to a manufacturing issue.Most likely a mishandling of the device led to the opening of this complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 03.610.602, lot: 52p9784, manufacturing site: hägendorf , release to warehouse date: 19 june 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11022944
• Report Number: 8030965-2020-09807
• Device Sequence Number: 19957244
• Product Code: HXX
• UDI-Device Identifier: 07611819895508
• UDI-Public: 07611819895508
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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 Catalogue Number: 03.610.602
• Device Lot Number: 52P9784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1