MAUDE Adverse Event Report: SYNTHES USA 2.0MM TI EMERGENCY SCREW W/FLUTED TIP 8MM; SCREW FIXATION,INTRAOSSEOUS

Catalog Number 400.788E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sedation (2368); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported that the plates were noticed to be loose sometime after a patient who underwent an orthognathic procedure.It was noted that the patient had a mal-union and delayed healing.The patient was brought back into surgery where it was discovered that the plates were broken.The plates and screws were removed along with cheek implants by another manufacturer.A new set of plates and screws were implanted to hold maxilla in position.The broken devices were reportedly difficult to remove and the procedure was extended by two hours.The patient status is reported as good.The maxilla is stable, but the patient will need another surgery to put new cheek implants in.This is report 13 of 23 for (b)(4).

Manufacturer Narrative

(b)(6).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.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

Additional narrative: subject device has been received and is currently in the evaluation process.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

Product investigation review: 20 screws and 3 plates of the orthognathic modular fixation system were returned for the plates reportedly breaking postoperatively.The construct reportedly failed after a lefort i orthognathic procedure, during which an osteotomy of the maxilla is performed and the bone is repositioned to correct a deficiency.The maxilla is then plated at the nasomaxillary (medial) and zygomaticomaxillary (lateral) buttresses.The brochure for the orthognathic modular fixation system was reviewed.The screws returned were all measured and verified to have outer diameters (od) of 2.0mm and 2.4mm.It is assumed the screws are emergency screws.The screws were returned in good condition.The left l-plate was returned broken at the third vertical hole.A 2.4mm od screw was stuck in the l-plate as well.The right l-plate was not broken.There were 4 pieces of another plate returned which is reportedly a 1.5mm ti adaption plate; however, this could not be verified.Product drawings were reviewed during the investigation.The returned plates are designed to be used with 1.5mm screws.If they do not purchase into the bone, 2.0mm emergency screws can be used.Three of the returned screws were 2.4mm emergency screws, however, and the hole diameter of the plates are only 2.1mm.Material from the plate may have been lost while inserting the 2.4mm emergency screws, compromising its strength.Excessive bending of the plates can produce internal stresses which may have also been a cause for the plates breaking.It is also unknown if the correct placement and number of plates were used for optimal stabilization of the maxilla.The complaint is confirmed as two of the plates returned were broken.The possible causes for the plate breakage include using the wrong screw sizes, excessive bending of the plates, and using the incorrect number of plates.The details of the technique are not known however and so the root cause cannot be determined.X-ray ((b)(6) 2014).Device 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 TI EMERGENCY SCREW W/FLUTED TIP 8MM
• Type of Device: SCREW FIXATION,INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4237999
• MDR Text Key: 5067062
• Report Number: 2520274-2014-14605
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK980199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400.788E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• 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 Weight: 70