MAUDE Adverse Event Report: SYNTHES USA PLATE BENDER FOR MIDFACE PLATES; INSTR,BENDING OR CONTOURING

Catalog Number 03.503.038

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2015

Event Type  Injury  

Manufacturer Narrative

Additional narrative: investigation summary for article 310.140 with lot no.: f-14365 ((b)(4) devices are involved) an investigation summary was performed.The investigation of the complaint articles has shown that the drill bits are broken off at the end of the flute.Also we found that the remaining flutes areas are worn out.The manufacturing review, of both articles, shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately we are not able to determine the exact cause of the breakage.Due to the wear and tear signs, we can assume that these products were often and intensive used instruments.We do suppose that the cause of the breakage is the result of a mechanical overload situation during use.The bad condition of the device, before surgery, may also have played a contributory negligence to the breakage.The microscopic analysis of the broken surfaces shows a homogenous surface what indicates material conformity.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Please note: blunt drill bits require more mechanical power during the application, therefore we recommend that blunt or damaged instruments need to be exchanged before surgery.We are not able to determine the exact cause of this occurrence as no detailed clinical information is available and therefore no corrective action can be defined.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 matrix mandible plate broke intraoperative during bending.A surgical delay of thirty (30) minutes was noted.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).The subject device was not received and no evaluation was performed.The evaluation reported in medwatch follow-up #1 was for a different device and these results were reported in error.As reported in the initial medwatch report for this device, the lot number is unknown and therefore, a review of the device history records could not be performed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PLATE BENDER FOR MIDFACE PLATES
• Type of Device: INSTR,BENDING OR CONTOURING
• 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: 4613950
• MDR Text Key: 13041903
• Report Number: 2520274-2015-11913
• Device Sequence Number: 1
• Product Code: HXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMP[T
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 62