MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.928

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is expected to be returned for manufacturer review/investigation but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported that a one (1) intermaxillary fixation screw broke during a procedure on (b)(6) 2018.The broken piece didn't fall inside of the patient.The broken screw was changed to a new device to complete the procedure.It is unknown if there was a surgical delay.There is no reported patient consequence.This report is for one (1) 2.0mm imf screw self-drilling 8mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.Device evaluated by mfr: a product investigation was conducted.Visual investigation: the threaded shaft is completely broken off; the remaining portion measures approximately 2.5 mm.The broken of threaded shaft measures approximately 8.1 mm and is completely damaged.The head cruciform drive is moderately damaged.The tops of the cross slots have displaced metal in the clockwise direction relative to torque applied.Dimensional inspection: the relevant dimensions can no longer be verified on manufacturing valid tolerances due to the location of the breakage and due to the existing damage on the broken off threaded spindle shaft.Drawing/specification review: the cause of the complained malfunction is a post-manufacturing caused use related breakage/damage due to mechanical overload to the device, therefore no drawing/specification review is required.Material review: a material review cannot be performed because of the unknown lot number.Conclusion: a final manufacturing conclusion cannot be presented because of product¿s condition and the unknown lot number.A visual inspection and comparison with the actual engineering drawing show that the device should have met the specification before the damage occurred.Based on the provided information we are not able to determine the exact cause of this occurrence.The appearance of the damage and fracture face indicates that a mechanical overloading situation, par example by exceptional hard bone, caused the breakage of these screws.In this relation we would like to point out the relevant surgical technique where on page 5 following is mentioned: in dense cortical bone, it may be necessary to predrill with a 1.5 mm drill bit.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 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.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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7794543
• MDR Text Key: 117577476
• Report Number: 8030965-2018-55801
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: K010527
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 10/24/2018
• Patient Sequence Number: 1