MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM CORTEX SCREW SELF-TAPPING 44MM; SCREW, FIXATION, BONE

Catalog Number 214.844S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional device product code: ktt.Reporter is a j&j employee.(b)(4).The device has been 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 that during an unknown surgery on an unknown date in 2020 the 4.5mm cortex screw broke while being inserted in locking compression (lcp) dynamic hip system (dhs) plate.The one half of the screw remained in the patient.Surgeon could not use the hole in the plate for fixation because of the broken screw and therefore surgeon replaced it with a longer plate with more holes.The surgery was delayed for twenty (20) minutes.Procedure was successfully completed.No further information provided.Concomitant device reported: dhs plate (part# unknown, lot# unknown, quantity# 1); screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 4.5mm cortex screw self-tapping 44mm.This is report 1 of 1 for complaint (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.H3, h4, h6- the investigation of the cortex screw has shown that at the screw is broken between the screw head and the threaded shaft.Furthermore, there are several mechanical damages at the hexagonal recess visible.The broken threaded shaft is not available for an evaluation.Therefore the complaint is rated as confirmed for this screw.The complaint is rated as confirmed for this cortex screw as the screw is is broken between the screw head and the threaded shaft.The exact cause of the breakage cannot be defined as there was just few information provided and as the fragment was not returned for further evaluation.Further investigation of the screw head has shown that are several mechanical damages at the hexagonal recess visible.This indication let us assume that the device encountered unintended forces, such as a mechanical overload during surgery, which finally caused the post manufacturing damages.The microscopic view of the broken surface at the threaded part of the screw head does not show any anomalies of materials structure.The damage pattern at the fracture face is an typical torsional forces.The cortex screw could not resist the applied force which finally let to the material overload / fatigue failure, for example metallic contact with the plate or the bone density was harder than normal.By the evidence, that the device passed our 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.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:214.844s, lot: 48p8398, manufacturing site: grenchen, release to warehouse date: 06 april 2020 , expiry date: 01.Mar.2030.A manufacturing record evaluation was performed for the finished device part: 214.844s, lot: 48p8398, 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6 investigation summary; additional information: dimensional inspection: document/drawing: feature/test/description: shaft diameter (near screw head): specification 3.7mm +/- 0.1.Actual 3.75mm.Results "pass".Feature/test/description: thread core inner diameter : specification 3.5mm +/- 0.1.Actual; 3.46mm.Results "pass".The measured dimensions were found to be within the given specifications per the drawings referenced above.Drawing/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 examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard iso 5832-1 for implants for surgery, stainless steel.The fracture face is homogenous, which indicates material conformity.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.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: 4.5MM CORTEX SCREW SELF-TAPPING 44MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10163530
• MDR Text Key: 195529644
• Report Number: 8030965-2020-04221
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819231078
• UDI-Public: (01)07611819231078
• Combination Product (y/n): N
• PMA/PMN Number: K161616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214.844S
• Device Lot Number: 48P8398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 07/29/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: DHS/DCS; UNK - SCREWDRIVERS
• Patient Outcome(s): Required Intervention