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

Catalog Number 201.928

Device Problem Bent (1059)

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

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the reporting facility.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 (b)(4) reported an event in (b)(6) as follows: it was reported that during an unspecified mandible surgery on (b)(6) 2017, the 2.0mm intermaxillary fixation (imf) 12mm length screw broke during blood suctioning and the tip was retained in the patient¿s jaw.The free fragments were removed by suction.The surgeon removed the retained fragment successfully with a small chisel and other instruments.When the surgeon attempted to place a second 2.0mm imf 8mm screw in the patient¿s upper jaw, the screw began to bend and the surgeon was unable to place it.A drill bit was used the place the remaining screws.The surgery was delayed for 20 minutes due to the reported events.Initially, the patient had an unspecified accident on an unknown date and was on the ultimate controlling institutional unit (uci unit) before surgery.The patient postsurgical outcome was reportedly stable.Reported concomitant devices: chisel (part / lot: unknown, quantity: 1), drill (part / lot: unknown, quantity: unknown.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Updated concomitant device, lot and udi number.Manufacturing location: (b)(6).Manufacturing date: october 04, 2016.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing facility.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

Updated concomitant device: drill (part: 317.780, lot: f-18267, quantity: 1).

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6426840
• MDR Text Key: 70634554
• Report Number: 2520274-2017-11019
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Device Lot Number: L159306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN CHISEL, QUANTITY 1; UNKNOWN DRILL, QUANTITY UNKNOWN
• Patient Weight: 80