MAUDE Adverse Event Report: SYNTHES MEZZOVICO 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW FIXATION, INTRAOSSEOUS

Catalog Number 201.932S

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during an open reduction internal fixation bilateral mandible procedure, the first screw was put in and broke half way down the shaft on insertion.The next screw also broke during insertion.The broken ends were left in the patient; the patient was advised of this.There was a prolongation but not very long (exact timeframe is unknown).They tried to get the broken part of the screws out and then had to put in some new screws.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device broke during insertion; device was not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.This complaint is assessed as not related to sterilization.Thus, the documents for the corresponding non sterile part 201.932 lot 8593923 were reviewed with the following result: no non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: a manufacturing evaluation was completed: the device was received with the tip of the screw broken off.The relevant dimension of the screw was checked and found to be in compliance with the technical drawings and ao/asif specification.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard iso 5832-1.The fracture face is homogenous, which indicates material conformity and has the typical view of a forced rupture.No product fault could be detected.This lot was manufactured in september 2013.We are not able to determine the exact cause of this occurrence.It is likely that a mechanical overload, par example by an exceptional hard bone, caused this breakage.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 12MM
• Type of Device: SCREW FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3934976
• MDR Text Key: 4576974
• Report Number: 1000562954-2014-10134
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 201.932S
• Device Lot Number: 8684715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1