MAUDE Adverse Event Report: SYNTHES GMBH CORTSCR 3.5 SELF-TAP L14 TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.200.014TS

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported during a procedure on (b)(6) 2020, a screw turned and could not be inserted into the bone.The procedure was completed successfully with a 5 minute surgical delay.Concomitant device reported: unk - screwdrivers: trauma (part#: unknown, lot#: unknown, quantity 1).This is report 1 of 1 for (b)(4).

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.Review of the device history record(s) showed that there were no issues during the manufacture of the non-sterile product that would contribute to this complaint condition.,review of the device history record(s) showed that there were no issues during the manufacture of the non-sterile product that would contribute to this complaint condition.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.

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.H3, h4, h6- the conclusion of the investigation is based on the review of the dhr including inspection sheet, the visual inspection as well as on the results of dimensional inspection.The result of the investigation did not reveal any information that would indicate a defective screw.According to the dhr, the screw and the entire lot were produced to specification.The re-measurements confirmed a screw in specification.Relevant dimensions were measured, which contribute to a functioning screw.Furthermore, the optical inspection did not show any traces that would have caused a massive force effect.Due to a completely intact screw, it can therefore be assumed that the direction of rotation must have been wrong in the application (handling error).Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.Device history lot part: 04.200.014ts, lot: 5l79126, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 13.August 2019, expiry date: 01.August 2024.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part: 04.200.014, lot: 5l64490, manufacturing site: balsthal, release to warehouse date: 07.August 2019.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.

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.Review of the device history record(s) showed that there were no issues during the manufacture of the non-sterile product that would contribute to this complaint condition.,review of the device history record(s) showed that there were no issues during the manufacture of the non-sterile product that would contribute to this complaint condition.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: CORTSCR 3.5 SELF-TAP L14 TAN
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10635700
• MDR Text Key: 210024209
• Report Number: 8030965-2020-07738
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334178381
• UDI-Public: (01)07612334178381
• Combination Product (y/n): N
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2024
• Device Catalogue Number: 04.200.014TS
• Device Lot Number: 5L79126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 11/06/2020; 12/04/2020; 12/04/2020
• Supplement Dates FDA Received: 11/19/2020; 12/05/2020; 12/07/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS; UNK - SCREWDRIVERS