PLATE BENDER FOR MIDFACE PLATES 03.503.038

[13041903] 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.
Patient Sequence No: 1, Text Type: N, H10

[19507888] 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).
Patient Sequence No: 1, Text Type: D, B5

[19522175] 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.
Patient Sequence No: 1, Text Type: N, H10

[32596741] (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.
Patient Sequence No: 1, Text Type: N, H10