MAUDE Adverse Event Report: SYNTHES GMBH HELICAL BLADE/SCREW COUPLING SCREW; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.026

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2020

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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, the spiral blade was jammed and no longer detached.The surgery was completed successfully with 30 minutes delay.There was no patient consequence.This complaint involves two (2) devices.This report is for (1) helical blade/screw coupling screw.This is report 2 of 2 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.A product investigation was conducted.Visual inspection: the received connecscr f/tfna helic blade+scr is in used condition.Especially the top of the rotary knob is deformed from frequently hammering.Further investigation has shown that the thread at the shaft is damaged and therefore the instrument could not be used properly.Functional test: a functional test was performed with the returned tfna helical-blade impactor and has shown that it is not possible to assemble adequately the connection screw in question as the thread is damaged.Dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the received condition agree with the complaint description and the complaint therefore is confirmed.The received connecscr f/tfna helic blade+scr is in used condition.Especially the top of the rotary knob is deformed from frequently hammering.Further investigation has shown that the thread at the shaft is damaged and therefore the instrument could not be used properly.These indication led us assume that the device encountered unintended forces, such as a mechanical overload during surgery, or an inadequate handling during reprocessing, which finally caused the post manufacturing damages.By the evidence, that the device passed our 100% final inspection before the device left the manufacturing site we confirm that the cause of failure is not due to any manufacturing non-conformance's.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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.A device history record (dhr) review was conducted: part: 03.037.026, lot: l757416, manufacturing site: bettlach, release to warehouse date: 19.February 2018.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: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10878384
• MDR Text Key: 217656726
• Report Number: 8030965-2020-09129
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819642522
• UDI-Public: (01)07611819642522
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.026
• Device Lot Number: L757416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TFNA HELICAL-BLADE IMPACT