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

Catalog Number 201.928E

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.Patient initials (b)(6).Udi#: (b)(4) lot number unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that an 8mm imf screw was being placed in the patient's mandible.When the imf screw was half way down the resident tilted his hand slightly and the screw broke in half.There was approximately a 3-5 minute delay as they attempted to remove the tip of the imf screw from the bone.The broken imf screw piece was unable to be retrieved and still remains in the patient.Another screw was available to be used in a different location of the bone.It was reported that the surgery was completed successfully without any additional medical intervention and the patient status was reported as stable.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.A product development investigation was performed for the subject device (2.0mm imf screw self-drilling 8mm, part number 201.928e, lot number unknown).The subject device was returned with the reported complaint condition that the screw broke in half during insertion resulting in a fragment being retained in the patient¿s mandible.The subject device was received with the tip/shaft broken off as reported.Only 7.9mm of the device was returned.The received portion of the subject device was received in good condition with no other observable damage.Per the associated technique guide, it is recommended that the surgeon pre-drill the hole for the imf screws when inserting into dense cortical bone.Drawings (manufactured/current) for the device were reviewed.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.As previously reported, a device history record review could not be reviewed since the lot number of the subject device is unknown.The exact root cause of the complaint condition is unknown.It is likely the screw was being inserted into excessively hard bone, and the lateral, levering force applied by the surgeon caused the screw to break.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5872811
• MDR Text Key: 52000692
• Report Number: 2520274-2016-14077
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR